FDA product code · Obstetrics and gynecology

Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs

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

QHCClass II21 CFR 876.1075510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.

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

Planning a device in QHC? 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

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