Electrocautery, Gynecologic (And Accessories)

Who Makes This Device Type in China?

3 of the 6 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are based in Guangdong and Zhejiang.

Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Guangdong, contract manufacturer
Modern Medical Equipment Manufacturing Ltd. Guangdong, contract manufacturer
Ningbo Shun YE Medical Company, Ltd. Zhejiang, contract manufacturer
Shenzhen JPY ION-Tech. Co., Ltd. Guangdong, contract manufacturer
Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. Zhejiang
Zhejiang Shuyou Surgical Instrument Co., Ltd. Zhejiang, contract manufacturer

How Is HGI Classified?

Electrocautery, Gynecologic (And Accessories) is FDA product code HGI, Class 2, 21 CFR 884.4120.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 24 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Component design/selection (7), Device Design (4) and Nonconforming Material/Component (1).

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

Electrocautery, Gynecologic (And Accessories)

Loop Electrodes 10x10mm

Loop Electrodes 10x10mm Box 20

Electrocautery, Gynecologic (And Accessories)

H-Series Loop Electrode

Catalogue number 13-2010, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Ball Electrodes

2 catalogue numbers from 2-3-2, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Gyrus Acmi

Disposable Bipolar Cord Vista CTR System Patent Pending

Electrocautery, Gynecologic (And Accessories)

Foot Pedal-Operated Cautery Pencil

Foot Pedal-Operated Cautery Pencil, 1 Box of 10

Electrocautery, Gynecologic (And Accessories)

Enseal X1

ENSEAL 20 cm shaft, Large Jaw

Electrocautery, Gynecologic (And Accessories)

Ball Electrodes 3mm Diameter

Ball Electrodes 3mm Diameter Box 20

Electrocautery, Gynecologic (And Accessories)

Imco

Electrosurgical Dermal Tip, Blunt

Electrocautery, Gynecologic (And Accessories)

Leep Precision™ Integrated System

LEEP PRECISION™ Integrated System (230 VAC)

Electrocautery, Gynecologic (And Accessories)

Enseal

ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length

Electrocautery, Gynecologic (And Accessories)

Loop Electrodes 20x8mm

Loop Electrodes 20x8mm Box 20

Electrocautery, Gynecologic (And Accessories)

Liger Medical

IRIS Thermocoagulator and Digital Colposcope

Electrocautery, Gynecologic (And Accessories)

Wallach

Quantum 2000 Electrosurgical Generator (120 VAC)

Electrocautery, Gynecologic (And Accessories)

Needle Electrodes

Catalogue number 15-0001, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Leep System 1000® Workstation

LEEP System 1000® Workstation (110 VAC)

Electrocautery, Gynecologic (And Accessories)

Leep Precision™ Generator

LEEP PRECISION™ Generator (120 VAC)

Electrocautery, Gynecologic (And Accessories)

Ball Electrodes 5mm Diameter

Ball Electrodes 5mm Diameter Box 20

Electrocautery, Gynecologic (And Accessories)

Square Electrodes 10x8mm

Square Electrodes 10x8mm SQ Box 20

Electrocautery, Gynecologic (And Accessories)

Square Electrodes 10x10mm

Square Electrodes 10x10mm SQ Box 20

Electrocautery, Gynecologic (And Accessories)

Carrera Loop Electrode

2 catalogue numbers from OCMR-1508, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Dual Dispersive Electrodes With Connector

Dual Dispersive Electrodes with Connector, 1 Box of 10

Electrocautery, Gynecologic (And Accessories)

Electrode Extender

Catalogue number 12-0000, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Loop Electrodes 15x8mm

Loop Electrodes 15x8mm Box 20

Electrocautery, Gynecologic (And Accessories)

Loop Electrodes 20x10mm

Loop Electrodes 20x10mm Box 20

Electrocautery, Gynecologic (And Accessories)

Leep Square Condyloma Electrode

LEEP Square Condyloma Electrode; 5.5cm Shaft; 15 Degree Bend

Electrocautery, Gynecologic (And Accessories)

Hand Switch-Operated Cautery Pencil

Hand Switch-Operated Cautery Pencil, 1 Box of 10

Electrocautery, Gynecologic (And Accessories)

Carrera Ball Electrodes

2 catalogue numbers from OCMB-2-3-2, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

CooperSurgical, Inc.

1X Macro Bipolar Insert (Long)

Electrocautery, Gynecologic (And Accessories)

Leep System 1000® Generator

2 catalogue numbers from L1000, listed by Coopersurgical, Inc., United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

QKit Procedure Tray

For LOOP Electrosurgical Excision Procedure - contains Lidocaine with Epinephrine

Electrocautery, Gynecologic (And Accessories)

Fischer Cone

Biopsy Excisor Convenience Kit

Electrocautery, Gynecologic (And Accessories)

Dual Dispersive Electrodes Without Connector

Catalogue number LP-50-202, listed by Coopersurgical, Inc., United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Leep Macro Needle Electrode

LEEP Macro Needle Electrode with 16mm Needle Electrode and 5.5cm Shaft

Electrocautery, Gynecologic (And Accessories)

Tungsten Loops

Tungsten Loops Round TIP

Electrocautery, Gynecologic (And Accessories)

Leep Square Electrode

LEEP Square Electrode; 12cm Shaft

Electrocautery, Gynecologic (And Accessories)

Leep Micro Needle Electrode

LEEP Micro Needle Electrode with 5mm Needle Electrode and 5.5cm Shaft

Electrocautery, Gynecologic (And Accessories)

Square Loop Electrodes

2 catalogue numbers from 19-1004, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Greenwald Surgical Device Company, Inc.

Active Machine Cord W/Bovie Machine Plug

Electrocautery, Gynecologic (And Accessories)

Loop Electrodes 20x15mm

Loop Electrodes 20x15mm Box 20

Electrocautery, Gynecologic (And Accessories)

Gynex

6 catalogue numbers from 14-1015, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Olympus

Disposable loop electrode,10*10mm

Electrocautery, Gynecologic (And Accessories)

H-Series Loop Electrodes

4 catalogue numbers from 13-1505, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Aesculap

METZENBAUM (MINI) ADTEC BIPOLAR Dissecting Scissors, complete instrument, bipolar, curved to left, working length: 12 1/4", (310 mm), diam. 5 mm, (14 mm), blunt/blunt, rotatable, insulated,…

Electrocautery, Gynecologic (And Accessories)

Medline

Tungsten Micro NDL W/Insulation 1 CM

Electrocautery, Gynecologic (And Accessories)

Henry Schein

H-Type Blunt Tip Disposable El

Electrocautery, Gynecologic (And Accessories)

Loop Electrodes 10x5mm

Loop Electrodes 10X5mm Box 20

Electrocautery, Gynecologic (And Accessories)

Sklar®

Ster Lletz Loop Elec 20X8 BX/5

Electrocautery, Gynecologic (And Accessories)

Conmed

CONMED ELECTROSURGICAL ACCESSORY, Loop Excision Electrode, 20 mm x 10 mm

Electrocautery, Gynecologic (And Accessories)

Leep Vaginal Electrode

LEEP Vaginal Electrode; 8 cm Shaft; 15 Degree Bend

Electrocautery, Gynecologic (And Accessories)

Cure Medical

Battery-operated, hand-held thermocoagulator.

Electrocautery, Gynecologic (And Accessories)

Fischer Cone Biopsy Excisor

Fischer Cone Biopsy Excisor; Small Wide Angle Extended

Electrocautery, Gynecologic (And Accessories)

Loop Electrodes 15x10mm

Loop Electrodes 15x10mm Box 20

Electrocautery, Gynecologic (And Accessories)

Harmonic

Enseal X1 Straight 37CM Shaft

Electrocautery, Gynecologic (And Accessories)

Disposable Super CUT Fine Needle

Disposable Super CUT Tungsten Carbide Modified Fine Needle With Heat Shrink SET

Electrocautery, Gynecologic (And Accessories)

Medline Industries, Inc.

Blade Modified 6IN SS

Electrocautery, Gynecologic (And Accessories)

Radius Loop ELectrodes

13 catalogue numbers from 12-2010, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Valleylab

Tungsten Square Loop Electrode

Electrocautery, Gynecologic (And Accessories)

Leep Ball Electrode

LEEP Ball Electrode; 3mm Diameter and 12cm Shaft

Electrocautery, Gynecologic (And Accessories)

Bovie

Extended Blade 6" (15.24 cm) Standard

Electrocautery, Gynecologic (And Accessories)

Leep Radius Electrode

LEEP Radius Electrode; 2.0cm x 1.0cm; 12cm Shaft

Electrocautery, Gynecologic (And Accessories)

DeRoyal

St. LLETZ Square Loop Electrode

Electrocautery, Gynecologic (And Accessories)

Valleylab

Private Label Medtronic Covidien 5mm X 5mm Square Loop (5/box)

Electrocautery, Gynecologic (And Accessories)

Greenwald Surgical Company, Inc.

Detached machine cord for P143 Bovie Model Number should be 77520-1

Electrocautery, Gynecologic (And Accessories)

McKesson

H-Type Dermal Tip Electrodes Blunt | Non-sterile

Electrocautery, Gynecologic (And Accessories)

Megadyne

LLETZ Loop Electrode, 10mm wide x 10mm deep, 11.8 cm shaft, yellow

Electrocautery, Gynecologic (And Accessories)

Premier

Trucone Electrode 18MM X 12MM 5-PK

Electrocautery, Gynecologic (And Accessories)

Carrera Loop Electrodes

19 catalogue numbers from CMR-2510, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.

Electrocautery, Gynecologic (And Accessories)

Bovie

Extended Modified Needle Blade Electrode 6'' (15.24CM) 0.75"' (1.90CM)

Electrocautery, Gynecologic (And Accessories)

Electrocautery, Gynecologic (And Accessories)

Square Loop, Loop Size: 10mm x 10mm

Electrocautery, Gynecologic (And Accessories)

Weck

Disposable Standard 3/4" Blunt Needle Electrode Sterile Electrosurgical Electrode

Electrocautery, Gynecologic (And Accessories)

Argent

Electrode, Ball Ext'd 5MM

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