Data / Medical devices / Guide, Surgical, Instrument

Guide, Surgical, Instrument (FZX): 439 FDA-registered makers in 27 countries

439 establishments in 27 countries are registered with the FDA to make Guide, Surgical, Instrument (product code FZX, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on February 16, 1994, and lists 25 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

FZX

Device class

1

Regulation

878.4800

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Guide, Surgical, Instrument

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 February 16, 1994. 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.