510(k) Report

FDA product code · Obstetrics and gynecology

Clip, Tubal Occlusion

HGBClass III21 CFR 884.5380PMA required0 decisions1 recall

0 FDA decisions. 1 recall names this code; it is not Class I.

Call for PMAs 12/30/87 (52 FR 36883 10/1/87))

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 HGB 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 · HGB

FDA has decided no HGB device since 2007.

Median 510(k) review, days · HGB

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

Recalls per year · HGB

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HGB

12in 2020

2007: 32008: 32009: 72010: 12011: 22013: 62014: 12015: 42016: 12020: 12
2007high 12 (2020) · low 0 (2012)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—03
20090—17
20100—01
20110—02
20120—00
20130—06
20140—01
20150—04
20160—01
20170—00
20180—00
20190—00
20200—012
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — HGB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HGB? 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 884.5380.