OLYMPUS CD-6C-1 COAGULATION ELECTRODE
FDA 510(k) clearance K971328 · decided 1997-07-01
Clearance details
- K-number
- K971328
- Device name
- OLYMPUS CD-6C-1 COAGULATION ELECTRODE
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-10
- Decision date
- 1997-07-01
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- FFE
- Device class
- 2
- Regulation number
- 876.4650
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.