FDA product code · General and plastic surgery

Operating Room Accessories Table Tray

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

FWZClass I21 CFR 878.495061 decisions since 197622 recalls

61 FDA decisions since 1976. 22 recalls name this code, 8 of them Class I.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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 FWZ 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 · FWZ

FDA has decided no FWZ device since 2007.

Median 510(k) review, days · FWZ

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

Recalls per year · FWZ

2in 2015

2007high 8 (2014) · low 0 (2011)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · FWZ

52in 2025

2007high 464 (2020) · low 8 (2007)2025

MAUDE reports naming product code FWZ, 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	—	1	8
2008	—	2	23
2009	—	1	16
2010	—	1	21
2011	—	0	31
2012	—	4	29
2013	—	0	42
2014	—	8 (8)	37
2015	—	2	69
2016	—	0	59
2017	—	0	102
2018	—	0	120
2019	—	0	99
2020	—	0	464
2021	—	0	337
2022	—	0	56
2023	—	0	28
2024	—	0	68
2025	—	0	52
2026	—	0	—

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

Planning a device in FWZ? 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 878.4950.

LWG Surgical Table Cushion FZK Chair, Surgical, Non-Electrical EPW Support, Head, Surgical, Ent FSE Table, Operating-Room, Manual FWX Table, Operating-Room, Mechanical FWY Table, Operating-Room, Non-Electrical JEB Table, Surgical With Orthopedic Accessories…BWN Table And Attachments, Operating-Room FZM Stool, Operating-Room

Operating Room Accessories Table Tray

What has FDA decided in FWZ lately?

What has been recalled in FWZ lately?

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