Data / Medical devices / Instrument, Biopsy

Instrument, Biopsy (KNW): 113 FDA-registered makers in 16 countries

113 establishments in 16 countries are registered with the FDA to make Instrument, Biopsy (product code KNW, Class 2, 21 CFR 876.1075). 63 of them have a 510(k) clearance or PMA approval on file and 11 have a recall event. The FDA has issued 365 510(k) clearances under this code, the latest on August 28, 2026, and lists 61 recall events (2 Class I). FDA data exported November 2, 2026.

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Product code

KNW

Device class

2

Regulation

876.1075

Medical specialty

Gastroenterology, Urology

Makers by country

Makers of Instrument, Biopsy

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 August 28, 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.