FDA product code · Obstetrics and gynecology

Laparoscopic Accessories, Gynecologic

Name: FDA decisions, review times, recalls and adverse event reports for product code NWV
Creator: 510(k) Report

NWVClass I21 CFR 884.1720510(k) exempt0 decisions1 recall

FDA lists NWV as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 884.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 1 recall names this code; it is not Class I.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, obstetrics and gynecology panel

Twenty years of NWV at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NWV

FDA has decided no NWV device since 2007.

Median 510(k) review, days · NWV

Too few NWV 510(k)s in any year since 2007 to give a median.

Recalls per year · NWV

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NWV

11in 2025

2007high 123 (2021) · low 0 (2007)2025

MAUDE reports naming product code NWV, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	13
2010	—	0	0
2011	—	0	0
2012	—	0	2
2013	—	0	0
2014	—	0	7
2015	—	1	23
2016	—	0	26
2017	—	0	31
2018	—	0	23
2019	—	0	56
2020	—	0	105
2021	—	0	123
2022	—	0	20
2023	—	0	25
2024	—	0	31
2025	—	0	11
2026	—	0	—

FIG. 1 — NWV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NWV? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 884.1720.

OCQ Laparoscopic Bladder-Neck Suspension…OKX Trocar Kit OHD Gynecological Laparoscopic Kit NMH Laparoscope And Accessories, Gynecologic…HET Laparoscope, Gynecologic (And Accessories)OHM Cesarean Section Tray

Laparoscopic Accessories, Gynecologic

What has been recalled in NWV lately?

Related product codes