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Trabeculotome

AURORA SURGICAL, LLC · Model AS14-205R · UDI-DI 08175700156554

HNJ
3
510(k) clearances
12
Adverse events
1
Recalls
78
Facilities

Description

Harms Trabeculotome, Right, Stainless Steel

Recalls

DateFirmReason
2013-06-27Insight Instruments, Inc.The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.