URETHRAL DILATOR ENDOSCOPE
FDA 510(k) clearance K874530 · decided 1988-01-27
Clearance details
- K-number
- K874530
- Device name
- URETHRAL DILATOR ENDOSCOPE
- Applicant
- Advanced Surgical Intervention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-03
- Decision date
- 1988-01-27
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- KOB
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.