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Novo Surgical
NOVO SURGICAL, INC. · Model UR6280-13 · UDI-DI 00842331119019
EZO
Prescription
5
510(k) clearances
69
Adverse events
1
Recalls
37
Facilities
Description
otis urethrotome, straight, complete w/ case, consisting of: 1 dilator apparatus (# 5179-05), 1 blade (# 5179-10), 1 conical tip (# 5179-11), 1 flat tip (# 5179-12), 1 ball tip (# 5179-13)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-22 | Olympus America Inc. | The device sterile package seal shows evidence of being breached or was breached |
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Get your free API keyRead the docsData 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.