COAXIAL BALLOON URETHRAL DILATOR
FDA 510(k) clearance K831384 · decided 1983-07-26
Clearance details
- K-number
- K831384
- Device name
- COAXIAL BALLOON URETHRAL DILATOR
- Applicant
- Thomas J. Fogarty, M.D.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-28
- Decision date
- 1983-07-26
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- FAH
- Device class
- 2
- Regulation number
- 876.5520
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Thomas J. Fogarty
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DILATING URETHRAL SOUND (K933957) | Cook Urological, Inc. | 1993-11-17 |
| MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER (K902370) | Boston Scientific Corp | 1990-08-17 |
| DOWD CATHETER (K902124) | Boston Scientific Corp | 1990-08-09 |
Recalls involving this device
No recalls on record reference this clearance.