FDA product code · Obstetrics and gynecology

Hysteroscope Accessories

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

NWWClass I21 CFR 884.1690510(k) exempt0 decisions0 recalls

FDA lists NWW 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. No recall names this code.

Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization.…

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 NWW 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 · NWW

FDA has decided no NWW device since 2007.

Median 510(k) review, days · NWW

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

Recalls per year · NWW

No recall names NWW since 2007.

Adverse event reports per year · NWW

13in 2025

2007high 13 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	2
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	5
2018	—	0
2019	—	1
2020	—	1
2021	—	4
2022	—	4
2023	—	10
2024	—	11
2025	—	13
2026	—	—

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

Planning a device in NWW? 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 884.1690.

HIH Hysteroscope (And Accessories)PTE Endoscopic Morcellator Gastroenterology QHZ Seal, Cervical, Mechanical, Unpowered MKO Falloposcope