Laparoscope, Gynecologic (And Accessories)

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Zhejiang and Jiangsu: 7 hold an FDA registration. 1 is a contract manufacturer.

Guangdong Optomedic Technologies, Inc. Guangdong
Global Medical Production Co., Ltd. Zhejiang
Hangzhou Fushan Medical Appliance Co., Ltd. Zhejiang, contract manufacturer
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Guangdong, contract manufacturer
Modern Medical Equipment Manufacturing Ltd. Guangdong, contract manufacturer
Scivita Medical Technology Co., Ltd. Jiangsu
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Zhejiang

How Is HET Classified?

Laparoscope, Gynecologic (And Accessories) is FDA product code HET, Class 2, 21 CFR 884.1720.

What Does It Take to Sell It in the United States?

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. Chinese applicants hold 3 clearances under this code; the FDA took a median of 206 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 19 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (5), Process control (4) and Device Design (3).

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

Laparoscope, Gynecologic (And Accessories)

10mm Spoon Forcep, Ratcheting Handle, With Rotation

Catalogue number EP4240RR, listed by Encision, Inc., United States, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

4k Cable 8.5m

Catalogue number MAJ-2254, listed by Olympus Medical Systems Corp., Japan, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

DR. Moore LAP KIT

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR…

Laparoscope, Gynecologic (And Accessories)

Endo Mini-Shears

Catalogue number 174301, listed by Covidien LP, United States, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

ValveGate™ Endoscope 5mm, Direction of View 30°, Autoclavable, 30cm

Catalogue number 34-0961.AC, listed by Geister Medizintechnik Gmbh, Germany, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

Ribbed Cannula

The Universal Cannula is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures.

Laparoscope, Gynecologic (And Accessories)

Round Tip Allis Grasping Forcep, Ratcheting Handle, With Rotation, 35cm

Catalogue number EP3100RR, listed by Encision, Inc., United States, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

Maynard LC

Kit Contains: CTF73, 12x100 Kii® Fios® ZTHR 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTF03, 5x100 Kii®…

Laparoscope, Gynecologic (And Accessories)

Centinela LAP Chole KIT

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF03, 5x100 Kii® Fios®…

Laparoscope, Gynecologic (And Accessories)

Protective Tube 20mm

Catalogue number 5139NOU, listed by Nouvag AG, Switzerland, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

DR. Roller/Kwon Roux EN Y

Kit Contains: CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTR03, 5x100 Kii® OPT ZTHR 6/BX CA090, DIRECT DRIVE® LCA 3/BX CB040, 5mmx45cm EPIX® LAPA SCISSOR, 10/BX CTR73 12X100 Kii® OPT ZTHR 6/BX

Laparoscope, Gynecologic (And Accessories)

DR. Bertram’s LAP Pack

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX

Laparoscope, Gynecologic (And Accessories)

Ultimate Diltating Tip Trocar With Ribbed Cannula

Catalogue number PS3475ULT, listed by Purple Surgical International Limited, United Kingdom, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

DR. Harris LAP Chole

Kit Contains: CTR03, 5x100 Kii® OPT ZTHR 6/BX CTR73 12X100 Kii® OPT ZTHR 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX C4120, 38CM GRASPER REPOS CART,…

Laparoscope, Gynecologic (And Accessories)

Ultimate Dilating Tip Trocar Kit With Ribbed Cannula+ Additional Cannula

Catalogue number PS3464ULT, listed by Purple Surgical International Limited, United Kingdom, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

Ripple Claw Forcep, 45cm, 23mm Jaw

Catalogue number EP3480-45 RR, listed by Encision, Inc., United States, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

10mm Claw Forcep, Ratcheting Handle, With Rotation

Catalogue number EP4200RR, listed by Encision, Inc., United States, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

Chole KIT 23

Kit Contains: C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTS02, 5x100 Kii…

Laparoscope, Gynecologic (And Accessories)

KE050 LAP

Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX…

Laparoscope, Gynecologic (And Accessories)

Laparoscopic Suction/ Irrigation Set Single Spike

The Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument.

Laparoscope, Gynecologic (And Accessories)

Tube FOR Mictec Spray

Tube FOR Mictec Spray Nozzle Double Angled

Laparoscope, Gynecologic (And Accessories)

DR. Murphy, Sontchi LAP Chole

Kit Contains: CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CFB03, 5x100 Kii® SH BLD ADVFIX, 6/BX CA090, DIRECT DRIVE® LCA 3/BX C0R47, 12x100 Kii® BALLOON…

Laparoscope, Gynecologic (And Accessories)

Non-ICG 5mm Laparoscope (0 Deg)

Catalogue number FG-16, listed by SmartsurgN, Inc., United States, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

KIT KE194 Cole B

Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE LCA 3/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX CTF35, 11x100 Kii Fios Z-THREAD DP…

Laparoscope, Gynecologic (And Accessories)

Symmetry Mckernan

Symmetry® Forceps, Mckernan Tri-Grasping, Fenestrated, Ratcheting Handle, 5 mm

Laparoscope, Gynecologic (And Accessories)

Auto-Shield Trocar, Ribbed Cannula Plus Extra Cannula

Catalogue number PS3514, listed by Purple Surgical International Limited, United Kingdom, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

4k UHD Camera System

The 4K UHD Camera System provides images of the operative area during endoscopic surgery. Model ES-CS4K100/100C combines an ES-CS4K100 camera control unit with an ES-CS4K100C camera head.…

Laparoscope, Gynecologic (And Accessories)

KIT KE063 Cole

Kit Contains: CTB12, 5x100 Kii SH BLD ZTHR DP 10/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CA090, DIRECT DRIVE LCA 3/BX C2201, 120MM INSUFF NEEDLE XE,…

Laparoscope, Gynecologic (And Accessories)

5mm Endo Babcock Forcep, Ratcheting Handle, With Rotation

Catalogue number ES0534RR, listed by Encision, Inc., United States, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

CHS (MID Florida) 5mm #2(001114)

Kit Contains: CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CTF73, 12x100 Kii®…

Laparoscope, Gynecologic (And Accessories)

10mm Babcock Short Jaw, 35cm, Ratcheting Handle, With Rotation

Catalogue number EP4300RR, listed by Encision, Inc., United States, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

CUS Universal KIT

Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTR24, 5x100 Kii® LP OPT…

Laparoscope, Gynecologic (And Accessories)

DR. Nelson’s KIT

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTB33, 11X100 Kii® SH BLD…

Laparoscope, Gynecologic (And Accessories)

Endo Clinch Extreme Atraumatic, 35cm Slide Lock Rotatable Handle

Catalogue number ES0535SLR, listed by Encision, Inc., United States, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Laparoscope, Gynecologic (And Accessories)

Total 5mm Solution KIT

Kit Contains: CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CB030, 5mmx35cm EPIX® LAPA…

Laparoscope, Gynecologic (And Accessories)

DR. Whitehurst LAP Chole Pack

Kit Contains: C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm…

Laparoscope, Gynecologic (And Accessories)

Hasson Pack

Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX C0R95, 12x100 Kii® BLUNT TIP SM CONE 6/BX CTB03, 5x100 Kii® SH BLD ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX

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