What is FDA product code NWV?

Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Obstetrics & Gynecology › DiagnosticLaparoscopic Accessories, Gynecologic

LAP Chole KIT- DR. Navarro

Name: LAP Chole KIT- DR. Navarro
Brand: LAP Chole KIT- DR. Navarro

Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTB03, 5x100 Kii® SH BLD ZTHR 6/BX CB030, 5mmx35cm EPIX®…

Registry build 21.09.26

Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTS02, 5×100 Kii® SLEEVE ZTHR 12/BX C0R47, 12×100 Kii® BALLOON BLUNT TIP 6/BX CTB03, 5×100 Kii® SH BLD ZTHR 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C4119, 32CM GRASPER REPOS CART, 10/BX

7manufacturers in China registered for this device type

1catalogue number

5recalls on this code

Who Else Makes It

Concentrated in Zhejiang (3), Anhui (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NWV
Manufacturer	City	Province	Registered as	Device types
Tonglu Qianyan Medtech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	7
Hangzhou Endo Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	19
Anhui Shiyin Photoelectric Instrument Co., Ltd.	Suzhou	Anhui	Specification developer	18
Tonglu Youshi Medical Instrument Co., Ltd.	Tonglu	Zhejiang	Manufacturer	10
Anqing Changfan Medical Instrument Co., Ltd.	Anqing	Anhui	Manufacturer	9
Suzhou SMH Co., Ltd.	Suzhou	Jiangsu	Manufacturer	4
Hunan Handlike Minimally Invasive Surgery Co., Ltd.	Changsha	Hunan	Manufacturer	3

Record

Regulatory record for LAP Chole KIT- DR. Navarro
Listed by	Applied Medical Resources Corp., United States
FDA product code	NWV
Device type	Laparoscopic Accessories, Gynecologic
Device class	Class 1
Regulation	21 CFR 884.1720
Establishment	Contract manufacturer, Complaint-file establishment, Manufacturer
Record published	2015-10-16
Record revised	2024-08-07 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for LAP Chole KIT- DR. Navarro
Catalogue number	Size	Status
K2646		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Millennium	Avalign Technologies, Inc.	201
AED	National Advanced Endoscopy Devices, Inc.	173
Elmed	Elmed, Inc.	36
Elite	National Advanced Endoscopy Devices, Inc.	8
Elmed Incorporated	Elmed, Inc.	7
AbGrab	Lapovations, LLC	6
Integra® Jarit®	Integra LifeSciences Production Corporation	5
Laparoscopic Accessories, Gynecologic	Stryker Sustainability Solutions	5
Speedlock	National Advanced Endoscopy Devices, Inc.	5
TroClear	Mednium Corporation	5
Integra® Miltex®	Integra LifeSciences Production Corporation	5
Eco Fit	National Advanced Endoscopy Devices, Inc.	4

Showing 12 of 80. All products under Laparoscopic Accessories, Gynecologic

Recalls

5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-03-17	Class II	Under Investigation by firm	There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.	32,760 units	2022-02-17
2020-03-17	Class II	Under Investigation by firm	There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.	12 units	2022-02-17
2020-03-17	Class II	Under Investigation by firm	There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.	4320 units	2022-02-17
2020-03-17	Class II	Under Investigation by firm	There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.	21 units	2022-02-17
2013-05-01	Class II	Nonconforming Material/Component	Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to	127,305 units	2014-02-06

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.