510(k) Report

FDA product code · Obstetrics and gynecology

Forceps, Surgical, Gynecological

HCZClass II21 CFR 884.4530510(k) required24 decisions since 19780 recalls

24 FDA decisions since 1978. No recall names this code. The most-cited predicate is K092840, named by 1 later device.

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 HCZ 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 · HCZ

1in 2018

2009: 12014: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCZ

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

Recalls per year · HCZ

No recall names HCZ since 2007.

Adverse event reports per year · HCZ

3in 2024

2007: 12008: 32009: 22013: 42014: 62017: 12018: 32022: 42024: 3
2007high 6 (2014) · low 0 (2010)2025

MAUDE reports naming product code HCZ, 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—01
20080—03
20091—02
20100—00
20110—00
20120—00
20130—04
20141—06
20150—00
20160—00
20170—01
20181—03
20190—00
20200—00
20210—00
20220—04
20230—00
20240—03
20250—00
20260—0—
FIG. 1 — HCZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HCZ? 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 884.4530.