Passer

Who Makes This Device Type in China?

6 manufacturers in China hold an FDA registration for this device type, concentrated in Shanghai, Anhui and Guangdong, and 2 other provinces. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Anqing Changfan Medical Instrument Co., Ltd. Anhui
Dongguan Senmed Medical Instrument Co., Ltd. Guangdong, contract manufacturer
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Qingdao Zhixing Medical Instrument Co., Ltd. Shandong
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Suzhou Elite Precision Machinery Co., Ltd. Jiangsu, contract manufacturer

What Is FDA Product Code HWQ?

Passer is FDA product code HWQ, Class 1, 21 CFR 888.4540.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 8 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (4), Equipment maintenance (1) and Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Cylox ST

16 catalogue numbers from Drill guide, listed by Signus Medizintechnik Gmbh, Germany, under Passer. 6 manufacturers in China are registered for this product code.

Arthrex

76 catalogue numbers from AR-8702, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Medline Renewal

AR-13991N Surefire Scorpion NDL Purple

Gsource

gWire Passer/Retriever Fcps 6", w/drill guide, OD 3.0mm, max cap 1.5mm [17 gauge] wire

Smith and Nephew

6 catalogue numbers from 110675, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Medline

251720 @ideal Suture Grasper, 15, (Grey)

Passer

Suture Slider 45 DEG. Right

Orthopediatrics Instrumentation

Tendon Passer, 2.4mm x 400mm

Nitinol Loop Passer

Nitinol Loop Passer: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Medicon

Bunnell tendon passer 23.0cm

Millennium

Flexible, Shunt Passer T-Handle 45cm Sharp Nose, Tip with Hole

Suture Passe

Dragon Tongue Suture Passer

Cuff Hook Left

Cuff Hook Left: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

EZ Pass

14 catalogue numbers from 904053, listed by Biomet Orthopedics, United States, under Passer. 6 manufacturers in China are registered for this product code.

Integra® Jarit®

Integra® Jarit® Bunnell Tendon Passer And Forwarding Probe

RiverPass

Orthopedic Surgical Needle

Conmed/Linvatec

24 catalogue numbers from C6384, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Proview

K-Wire Blunt Percutaneous MIS

Shuttle Pin

Shuttle Pin 1.1mm, 100mm Sterile, Qty1

Maci Arthroscopic Instruments

18mm V-Shuttle and Two-Pack MACI Applicator Kit

Passer

ProPass Suture Passer, with auto-capture

Progressive Medical; Inc.

2 catalogue numbers from PMI-TC-SG, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Suture Passer – Single Loop

Catalogue number DM-4890, listed by Dunamis Medical LLC, United States, under Passer. 6 manufacturers in China are registered for this product code.

Endobutton

2.4MM X 10 Inch Drill-TIP Guide Wire

Novo Surgical Inc.

tendon passer, pointed tip, 6" (15.0 cm), straight

Stryker

22 catalogue numbers from 3910-500-759, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Reprocessed Ideal Suture Grasper, 60 Deg

Catalogue number 251723, listed by Suretek Medical, United States, under Passer. 6 manufacturers in China are registered for this product code.

Suture Passer Straight

Suture Passer Straight: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Cable-Ready®

2 catalogue numbers from 2232-07-30, listed by Zimmer, Inc., United States, under Passer. 6 manufacturers in China are registered for this product code.

ConMed

6 catalogue numbers from 8570, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

NanoPass

Nanopass Classic Crescent

Passer

2.0MM Suture Passer 195MM

Ekcomed

Catalogue number EKM-SR10B, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Novo Surgical

bunnell tendon passer & probe, malleable, 5.0 mm diameter, 7-1/4" (18.5 cm)

Apex

Tissue Protection Sleeve - Short

CAP-FIX

CAP-FIX Suture Passer 70 DEG

Passer

Tendon Passing Hemostat

Cannu-Flex

Cannu-Flex Screw Guide Wire, 2 MM X 12 Inch 30 CM, Blunt TIP, Sterile

EZPass™

7 catalogue numbers from 904056, listed by Biomet Orthopedics, United States, under Passer. 6 manufacturers in China are registered for this product code.

Xiros

2 catalogue numbers from 202-1413, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

CapsulePass

Capsulepass 45 UP Suture Passer

Ambler Surgical

Tendon passer (braiding/weaving) forceps, 6'', straight, 6.0mm pointed tips, ring handle

Needle

Shuttle Needle

Inion® Shoulder Instrumentation

Suture passer, 45°

Slider Needle 45° Right

Slider Needle 45° Right: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

HNM Medical

Crawford Cooley Tunneler, 18"

Speedpass Disposable

7 catalogue numbers from 904001, listed by Biomet Orthopedics, United States, under Passer. 6 manufacturers in China are registered for this product code.

EasyPass

EasyPass Suture Passers, Frog, 70° Straight 205mm

Symmetry Bunnell

Symmetry® Stripper, Bunnell Tendon, 5.0 mm Diameter, Malleable, 7 1/4 in

25° Left, Champion®+ Slider With Nitinol Passing Wire

Catalogue number 3910-500-767, listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Slider Needle 60° Straight

Slider Needle 60° Straight: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Passing Needle Kit With Obturator

2 catalogue numbers from APNK1-5.0X, listed by AD-Tech Medical Instrument Corp., United States, under Passer. 6 manufacturers in China are registered for this product code.

Pilling

2 catalogue numbers from IPN928907, listed by Teleflex Medical LLC, United States, under Passer. 6 manufacturers in China are registered for this product code.

Citregen Tendon Sizing Kit

Catalogue number 70-811-0001, listed by Acuitive Technologies, United States, under Passer. 6 manufacturers in China are registered for this product code.

Symmetry Surgical

Symmetry® Probe, Bunnell Tendon Passer And Forwarding, 9 in, 228 mm

Monopoly

Catalogue number Forceps, hook, listed by Signus Medizintechnik Gmbh, Germany, under Passer. 6 manufacturers in China are registered for this product code.

Hip Suture Passer, Right

Hip Suture Passer, Right: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Bent Passing Needle Kit

2 catalogue numbers from BPNK1-10X, listed by AD-Tech Medical Instrument Corp., United States, under Passer. 6 manufacturers in China are registered for this product code.

Kmedic

2 catalogue numbers from IPN014057, listed by Teleflex Medical LLC, United States, under Passer. 6 manufacturers in China are registered for this product code.

P28 Needle

White/Blue UHMWPE Polyblend Non-Absorbable Loop Suture

Firstpass

Firstpass ST Suture Passer, Self Capture

Hip Suture Manipulator

Hip Suture Manipulator: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Suture Fisher Hip

Suture Fisher Hip - Suture Holder 45° to the Right

Passer

SET Screw FOR Suture Passer, Small. Meniscal Mender II

AC Slider Needle

Catalogue number 3910-500-795, listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

LaproClose

Laproclose Suture Passer, 180 MM Sutrure Passer, 14G, TWO Bariatric (XL) Length Guides (10/12 MM & 15 MM) AND TWO Trocar Swabs (5-8MM & 10-12 MM))

Paragon 28

Catalogue number P44-970-0001-SK, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Biorci

Cannu-Flex 1.5 MM X 305 MM.062 Inch X 12 Inch Guide Wire

Phoenix SFS

Bone Marrow Aspiration Needle, 11 Gage, 8" Length

Suture Lariat

2 catalogue numbers from 904022, listed by Biomet Orthopedics, United States, under Passer. 6 manufacturers in China are registered for this product code.

Slider Needle Crescent Large

Slider Needle Crescent Large: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Suture Passer 35° Up

Suture Passer 35° Up: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Patient Positioning Solutions, Inc.

2 catalogue numbers from PPS-32401, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Caplock

Caplock - Capsular Passer 45°

45° Left, Champion®+ Slider With Nitinol Passing Wire

Catalogue number 3910-500-765, listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Medline

Catalogue number DYNJSR01, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

SlingShot

Slingshot 70 UP

Suture Fisher

Suture Fisher - Suture Holder 45° to the Right

Slider Needle 30° Straight

Slider Needle 30° Straight: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

PunchTac Shuttle Wire Loop

Catalogue number DM-4830, listed by Dunamis Medical LLC, United States, under Passer. 6 manufacturers in China are registered for this product code.

Straight, Champion®+ Slider With Nitinol Passing Wire

Catalogue number 3910-500-762, listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

FlexPasser Tendon Retrieval Kit

Catalogue number 202-1500, listed by Xiros Ltd, United Kingdom, under Passer. 6 manufacturers in China are registered for this product code.

Champion Slider Handle

Champion Slider Handle: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Suture Passer

Suture Passer - Suture Transporter

Aspen Surgical

Catalogue number 710001, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Aesculap

BUNNELL Tendon Passer, 9" (230 mm)

OrthoPediatrics PediFoot Deformity Correction System

Tendon Passer

StabiliHook Left

StabiliHook Left: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Revolution

Catalogue number FG0008, listed by Siesta Medical, Inc., United States, under Passer. 6 manufacturers in China are registered for this product code.

Champion SlingShot

Champion Slingshot 45 Right

Slider Needle Crescent Medium XL

Slider Needle Crescent Medium XL: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

StabiliHook Right

StabiliHook Right: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Slider Needle 25° Right

Slider Needle 25° Right: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Avalign

Bunnell Tendon Passer,

Tornier Latitude

Suture Passer

Accu-Pass

Accu-Pass Direct; 45 DEG Right

Adler Instrument Company

Tendon Braiding Fcps 6 STR

Hip Suture Passer, Left

Hip Suture Passer, Left: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Beatty Marketing and Sales

3 catalogue numbers from 22701, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Hip Suture Passer — 35˚ Up

Hip Suture Passer — 35˚ Up: 2 catalogue numbers listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

CitreLock 2.4mm K-Wire, Trocar Tip

Catalogue number 40-101-0004, listed by Acuitive Technologies, United States, under Passer. 6 manufacturers in China are registered for this product code.

DePuy Mitek

Catalogue number 214141, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Hip Suture Passer, Straight

Hip Suture Passer, Straight: 3 catalogue numbers listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Integra®

Integra® Suture Passer

Slider Needle 45° Left

Slider Needle 45° Left: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Bone Mulch Suture Loop Passer

Catalogue number 906976, listed by Biomet Orthopedics, United States, under Passer. 6 manufacturers in China are registered for this product code.

Instrument

2 catalogue numbers from Holding forceps, listed by Signus Medizintechnik Gmbh, Germany, under Passer. 6 manufacturers in China are registered for this product code.

Slider Needle Crescent Medium

Slider Needle Crescent Medium: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Passing Needle Kit for 1-Tail Electrode

Catalogue number LPNK1-10X, listed by AD-Tech Medical Instrument Corp., United States, under Passer. 6 manufacturers in China are registered for this product code.

T.A.G.

Catalogue number 110026884, listed by Provision, under Passer. 6 manufacturers in China are registered for this product code.

Slider Needle 25° Left

Slider Needle 25° Left: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Accord

Cable Passer - Large

90° Tight Curve, Champion®+ Slider With Nitinol Passing Wire

Catalogue number 3910-500-764, listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Crescent, Champion®+ Slider With Nitinol Passing Wire

Catalogue number 3910-500-763, listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Symmetry In-Situ

Symmetry® Hook, In-Situ Bypass, Angled, Round Tip, 2 mm, 7 in, 177 mm

Slider Needle Crescent Large XL

Slider Needle Crescent Large XL: 1 catalogue number listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Reprocessed Hoffee Blue Lasso Suture Retriever

Catalogue number 022701, listed by Suretek Medical, United States, under Passer. 6 manufacturers in China are registered for this product code.

Diplomat

Catalogue number Sleeve, cross connector, listed by Signus Medizintechnik Gmbh, Germany, under Passer. 6 manufacturers in China are registered for this product code.

25° Right, Champion®+ Slider With Nitinol Passing Wire

Catalogue number 3910-500-768, listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

45° Right, Champion®+ Slider With Nitinol Passing Wire

Catalogue number 3910-500-766, listed by T.A.G Medical Products Agricultural Cooperative Association, under Passer. 6 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer