510(k) Report

FDA product code · Obstetrics and gynecology

Band, Tubal Occlusion

HFYClass III21 CFR 884.5380PMA required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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 HFY 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 · HFY

FDA has decided no HFY device since 2007.

Median 510(k) review, days · HFY

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

Recalls per year · HFY

No recall names HFY since 2007.

Adverse event reports per year · HFY

3in 2009

2009: 3
2007high 3 (2009) · low 0 (2007)2025

MAUDE reports naming product code HFY, 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—00
20080—00
20090—03
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — HFY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HFY? 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.

HGB Clip, Tubal OcclusionKNH Laparoscopic Contraceptive Tubal Occlusion…HDO Valve, Tubal OcclusionHHS Transcervical Contraceptive Tubal Occlusion…