Data / Medical devices / General Surgery Tray

General Surgery Tray (LRO): 106 FDA-registered makers in 16 countries

106 establishments in 16 countries are registered with the FDA to make General Surgery Tray (product code LRO, Class 2, 21 CFR 878.4370). 20 of them have a 510(k) clearance or PMA approval on file and 12 have a recall event. The FDA has issued 110 510(k) clearances under this code, the latest on May 24, 2022, and lists 251 recall events (35 Class I). FDA data exported November 2, 2026.

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Product code

LRO

Device class

2

Regulation

878.4370

Medical specialty

General, Plastic Surgery

Makers by country

Makers of General Surgery Tray

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 24, 2022. 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.