Data / Medical devices / Instrument, Manual, General Obstetric-Gynecologic

Instrument, Manual, General Obstetric-Gynecologic (KOH): 61 FDA-registered makers in 9 countries

61 establishments in 9 countries are registered with the FDA to make Instrument, Manual, General Obstetric-Gynecologic (product code KOH, Class 1, 21 CFR 884.4520). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on April 21, 2000, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

KOH

Device class

1

Regulation

884.4520

Medical specialty

Obstetrics/Gynecology

Makers by country

Makers of Instrument, Manual, General Obstetric-Gynecologic

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated April 21, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.