Data / Medical devices / Instrument, Ent Manual Surgical

Instrument, Ent Manual Surgical (LRC): 158 FDA-registered makers in 18 countries

158 establishments in 18 countries are registered with the FDA to make Instrument, Ent Manual Surgical (product code LRC, Class 1, 21 CFR 874.4420). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 65 510(k) clearances under this code, the latest on May 25, 2023, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

LRC

Device class

1

Regulation

874.4420

Medical specialty

Ear, Nose, Throat

Makers by country

Makers of Instrument, Ent Manual Surgical

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 May 25, 2023. 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.