FDA product code · Obstetrics and gynecology

Set, Anesthesia, Pudendal

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

HEGClass II21 CFR 884.5100510(k) required0 decisions0 recalls

0 FDA decisions. 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, obstetrics and gynecology panel

Twenty years of HEG 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 — HEG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HEG? 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 884.5100.

HEE Set, Anesthesia, Paracervical PVU Obstetrical Anesthesia Kit PVW Pudendal Anesthesia Kit KNE Set, Anesthesia, Obstetric PVV Paracervical Anesthesia Kit