Stylet, Surgical, General & Plastic Surgery

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Guangdong and Jiangsu: 3 hold an FDA registration. 1 is a contract manufacturer.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
Shenzhen Xinzhengyu Technology Co., Ltd. Guangdong

How Is GAH Classified?

Stylet, Surgical, General & Plastic Surgery is FDA product code GAH, Class 1, 21 CFR 878.4800.

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 Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2016. None was by a company in China. The root causes the FDA records most often are Mixed-up of materials/components (2) and Equipment maintenance (1).

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

Stylet, Surgical, General & Plastic Surgery

MR Stylet

Catalogue number 4013-06, listed by Clinical Laserthermia Systems AB, Sweden, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

LXS Stylet

Flexible stylet (accessory) to be used with the ONETRAC LXS Yankauer suction cannula

Stylet, Surgical, General & Plastic Surgery

Stylet, 285mm

Catalogue number 2004-0011, listed by OsteoCentric Technologies,Inc, United States, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Veta Peritoneal Dialysis Catheter

VETA Peritoneal Dialysis Stylet

Stylet, Surgical, General & Plastic Surgery

Blazer

Blazer Single Step Diamond Trocar Tip Introducer

Stylet, Surgical, General & Plastic Surgery

Visualase Neuro Accessories

Visualase Neuro Accessories (1) Anchor Bolt (1) Stiffening Stylet (1) Anchor Bolt Removal Tool

Stylet, Surgical, General & Plastic Surgery

1.8MM Cleaning Stylet F/Freer Suction Elevator (386.906)

Stylet, Surgical, General & Plastic Surgery

Pediguard Threaded

2 catalogue numbers from STARTER Pin 1, listed by Spineguard, SA, France, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

CONTOUR-Ribbed 2 – Instruments

Bone nail guidewire, reusable - General Instrument

Stylet, Surgical, General & Plastic Surgery

Autofix

Cleaning Stylet

Stylet, Surgical, General & Plastic Surgery

V. Mueller

V. Mueller SUTURE PULLER ROUND HANDLE WORKING LENGTH 10.5 inches 26.5CM OVERALL LENGTH 13.75 inches 35CM

Stylet, Surgical, General & Plastic Surgery

Gsource

Cleaning Stylet 8 1/2" str, Ø 2.5mm, ring hdl

Stylet, Surgical, General & Plastic Surgery

Link Instruments – Alignment and Positioning Instruments

Orthopaedic prosthesis implantation instrument, reusable - LINK SLED Prosthesis

Stylet, Surgical, General & Plastic Surgery

Styletstylet

Catheter Styletcatheter Stylet

Stylet, Surgical, General & Plastic Surgery

MP Reconstruction System – Instruments

Catalogue number 134-201/00, listed by Waldemar Link GmbH & Co. KG, Germany, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Integra® Jarit®

Integra® Jarit® Stylet for Suction Nasal Forceps and Punch Rongeurs

Stylet, Surgical, General & Plastic Surgery

Catheter Stylet

Stylet, Surgical, General & Plastic Surgery

Kiva

Kiva Diamond Tip Access Needle, 11GA

Stylet, Surgical, General & Plastic Surgery

Breckenridge Acdf System

Suction Tube Retractor Stylet

Stylet, Surgical, General & Plastic Surgery

Kmedic

Stylets Only FOR KM 42-825

Stylet, Surgical, General & Plastic Surgery

Verum System Surgical Instrument

4 catalogue numbers from CC0190, listed by Jeil Medical Corporation, South Korea, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Karl Storz

Catalogue number 8401DS, listed by Provision, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Proview

MIS Stylet

Stylet, Surgical, General & Plastic Surgery

Endo-Model Knee System – Instruments

Catalogue number 445-111/00, listed by Waldemar Link GmbH & Co. KG, Germany, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Visualase MR Stiffening Stylet

Visualase MR Stiffening Stylet (1) MR Stiffening Stylet

Stylet, Surgical, General & Plastic Surgery

Prometheus System Surgical Instrument

5 catalogue numbers from PRO-90026, listed by Jeil Medical Corporation, South Korea, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Osseoflex®

6 catalogue numbers from 00884450387405, listed by Merit Medical Systems, Inc., United States, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

General Instrument

2.8mm Cleaning Stylet

Stylet, Surgical, General & Plastic Surgery

FO Micro Screw System

FO Micro Cleaning Stylet

Stylet, Surgical, General & Plastic Surgery

Cardinal Health 200

Catalogue number IS14L, listed by Provision, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

OrthoPediatrics Cannulated Screw System

1.25mm Cleaning Stylet

Stylet, Surgical, General & Plastic Surgery

Visualase

Stylet 9735566 1MM Visualization

Stylet, Surgical, General & Plastic Surgery

Symmetry Frazier

Symmetry® Spare Part Suction Tube, Stylet, For Frazier Suction Tube 09-8308

Stylet, Surgical, General & Plastic Surgery

Teleflex

2 catalogue numbers from 502505, listed by Provision, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

MicroFrance®

Laryngeal Stylet Handle Rack MCL828C

Stylet, Surgical, General & Plastic Surgery

Nico BrainPath

95 mm Stylet

Stylet, Surgical, General & Plastic Surgery

Monster Screw System

Cannulated Cleaning Stylet, 2.3mm

Stylet, Surgical, General & Plastic Surgery

Response Spine System

Stylet - Luer Lock Cannulated Tap

Stylet, Surgical, General & Plastic Surgery

Millennium

Fine Stylet FOR Irrigation

Stylet, Surgical, General & Plastic Surgery

Surgical Instrument

6 catalogue numbers from 111-222, listed by Jeil Medical Corporation, South Korea, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Orthopediatrics Instrumentation

5.0mm Hex Cannulated Driver, Retaining Short

Stylet, Surgical, General & Plastic Surgery

Symmetry Rumel

Symmetry® Obturator, Rumel, Adult, 9 in

Stylet, Surgical, General & Plastic Surgery

Wexler Surgical, Inc.

9 catalogue numbers from HL1011.1, listed by Wexler Surgical, Inc., United States, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Summa Orthopaedics System Surgical Instrument

6 catalogue numbers from SO-111-067-3, listed by Jeil Medical Corporation, South Korea, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Disc Preparation Instruments

Suction Tube Retractor Stylet

Stylet, Surgical, General & Plastic Surgery

Lion

HT-B10

Stylet, Surgical, General & Plastic Surgery

Integra® Miltex®

Integra® Miltex® Stylet for Suction Nasal Forceps and Punch Rongeurs

Stylet, Surgical, General & Plastic Surgery

D.R Burton

Catalogue number 597-NSD, listed by Provision, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Medtronic

3 catalogue numbers from 85864, listed by Provision, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Inlet System Surgical Instrument

5 catalogue numbers from IN111-067-3, listed by Jeil Medical Corporation, South Korea, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Verathon

4 catalogue numbers from 0800-0608, listed by Provision, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Stylet, Surgical, General & Plastic Surgery

Who Makes This Device Type in China?

How Is GAH Classified?

How Does It Reach the US Market?

What Has Gone Wrong With It?

Where China Actually Supplies