FDA product code · General and plastic surgery

Prosthesis, Adhesive, External

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

GBJClass I21 CFR 878.3750510(k) exempt4 decisions since 19790 recalls

FDA lists GBJ 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. 4 FDA decisions since 1979. No recall names this code.

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 GBJ 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 · GBJ

FDA has decided no GBJ device since 2007.

Median 510(k) review, days · GBJ

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

Recalls per year · GBJ

No recall names GBJ since 2007.

Adverse event reports per year · GBJ

2in 2023

2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code GBJ, 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	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	2
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in GBJ? 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

Prosthesis, Adhesive, External

What has FDA decided in GBJ lately?