FDA product code · General and plastic surgery

Camera, Television, Endoscopic, Without Audio

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

FWFClass I21 CFR 878.4160510(k) exempt23 decisions since 19842 recalls

FDA lists FWF as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 23 FDA decisions since 1984. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K923160, named by 4 later devices.

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, general and plastic surgery panel

Twenty years of FWF 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 · FWF

FDA has decided no FWF device since 2007.

Median 510(k) review, days · FWF

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

Recalls per year · FWF

2in 2007

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FWF

27in 2025

2007high 40 (2019) · low 0 (2014)2025

MAUDE reports naming product code FWF, 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	—	2	1
2008	—	0	6
2009	—	0	1
2010	—	0	5
2011	—	0	2
2012	—	0	1
2013	—	0	6
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	4
2018	—	0	9
2019	—	0	40
2020	—	0	23
2021	—	0	28
2022	—	0	40
2023	—	0	25
2024	—	0	20
2025	—	0	27
2026	—	0	—

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

Planning a device in FWF? 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 878.4160.

KQM Camera, Surgical And Accessories FTS Camera, Cine, Endoscopic, With Audio FXR Holder, Camera, Surgical FWH Camera, Cine, Surgical, Without Audio SFG Camera, Surgical, Measurement FWK Camera, Cine, Microsurgical, With Audio FWD Camera, Television, Microsurgical, Without Audio FWB Camera, Television, Surgical, Without Audio FXS Frame, Camera, Surgical FWG Camera, Television, Endoscopic, With Audio FWC Camera, Television, Surgical, With Audio FTH Camera, Still, Microsurgical

Camera, Television, Endoscopic, Without Audio

Which predicates do FWF devices cite most?

Which FWF devices have the deepest lineage?

What has FDA decided in FWF lately?

What has been recalled in FWF lately?

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