Data / Medical devices / Hysteroscope (And Accessories)

Hysteroscope (And Accessories) (HIH): 86 FDA-registered makers in 16 countries

86 establishments in 16 countries are registered with the FDA to make Hysteroscope (And Accessories) (product code HIH, Class 2, 21 CFR 884.1690). 44 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 175 510(k) clearances under this code, the latest on September 25, 2026, and lists 13 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

HIH

Device class

2

Regulation

884.1690

Medical specialty

Obstetrics/Gynecology

Makers by country

Makers of Hysteroscope (And Accessories)

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 September 25, 2026. 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.