Data / Medical devices / Electrosurgical, Cutting & Coagulation & Accessories

Electrosurgical, Cutting & Coagulation & Accessories (GEI): 552 FDA-registered makers in 40 countries

552 establishments in 40 countries are registered with the FDA to make Electrosurgical, Cutting & Coagulation & Accessories (product code GEI, Class 2, 21 CFR 878.4400). 325 of them have a 510(k) clearance or PMA approval on file and 57 have a recall event. The FDA has issued 2,320 510(k) clearances under this code, the latest on October 20, 2026, and lists 253 recall events (7 Class I). FDA data exported November 3, 2026.

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Product code

GEI

Device class

2

Regulation

878.4400

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Electrosurgical, Cutting & Coagulation & 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 October 20, 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.