MALE EXTERNAL CATHETER
FDA 510(k) clearance K923136 · decided 1992-12-03
Clearance details
- K-number
- K923136
- Device name
- MALE EXTERNAL CATHETER
- Applicant
- Rochester Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-29
- Decision date
- 1992-12-03
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- EXJ
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Stewartville, MN, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FEMSOFT URETHRAL INSERT (P990002/S002) | Rochester Medical Corp. | 2013-03-21 |
| FEMSOFT URETHRAL INSERT (P990002/S001) | Rochester Medical Corp. | 2000-12-28 |
| FEMSOFT URETHRAL INSERT (P990002) | Rochester Medical Corp. | 1999-09-30 |