OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
FDA 510(k) clearance K973232 · decided 1997-11-21
Clearance details
- K-number
- K973232
- Device name
- OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
- Applicant
- Olympus Winter & Ibe GmbH
- Decision
- Substantially Equivalent
- Date received
- 1997-08-28
- Decision date
- 1997-11-21
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hamburg 70, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.