510(k) Report

FDA product code · Obstetrics and gynecology

Hook, Destructive, Obstetrical

HDIClass II21 CFR 884.4500510(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 HDI 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 · HDI

FDA has decided no HDI device since 2007.

Median 510(k) review, days · HDI

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

Recalls per year · HDI

No recall names HDI since 2007.

Adverse event reports per year · HDI

No MAUDE report names HDI since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
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 — HDI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HDI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 884.4500.

KNB Instrument, Destructive, Fetal, ObstetricHHN CleidoclastHFZ CraniotribeHGA Cranioclast