DILATING URETHRAL SOUND
FDA 510(k) clearance K933957 · decided 1993-11-17
Clearance details
- K-number
- K933957
- Device name
- DILATING URETHRAL SOUND
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-12
- Decision date
- 1993-11-17
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- FAH
- Device class
- 2
- Regulation number
- 876.5520
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER (K902370) | Boston Scientific Corp | 1990-08-17 |
| DOWD CATHETER (K902124) | Boston Scientific Corp | 1990-08-09 |
| COAXIAL BALLOON URETHRAL DILATOR (K831384) | Thomas J. Fogarty, M.D. | 1983-07-26 |
Recalls involving this device
No recalls on record reference this clearance.