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SURGISTAR

SURGISTAR, INC. · Model 330010 · UDI-DI 00878799005502

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

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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.