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Richard Wolf GmbH · Model 8670965 · UDI-DI 04055207019399

EZO
5
510(k) clearances
69
Adverse events
1
Recalls
37
Facilities

Description

SCALPEL 16.5FR CERAMIC SEMICIRCULAR for optical urethrotome, telescope Ø 3.3mm, central channel for 4Fr guide catheter, 12 O'clock cutting position, for slitting of urethral (transurethral) and ureteral (percutaneous) stenosis, reusable

Recalls

DateFirmReason
2010-12-22Olympus America Inc.The device sterile package seal shows evidence of being breached or was breached

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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.