FDA product code · Obstetrics and gynecology

Valve, Tubal Occlusion

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

HDOClass 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 HDO 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.

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

Planning a device in HDO? 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.

HFY Band, Tubal Occlusion HGB Clip, Tubal Occlusion KNH Laparoscopic Contraceptive Tubal Occlusion…HHS Transcervical Contraceptive Tubal Occlusion…