SILICONE MALE EXTERNAL CATHETER
FDA 510(k) clearance K913524 · decided 1991-10-04
Clearance details
- K-number
- K913524
- Device name
- SILICONE MALE EXTERNAL CATHETER
- Applicant
- Mentor Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-08
- Decision date
- 1991-10-04
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- EXJ
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| MENTOR MemoryGel Enhance Breast Implants (P030053/S081) | Mentor Corp. | 2025-06-18 |
| MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS (P030053/S079) | Mentor Corp. | 2025-05-21 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S078) | Mentor Corp. | 2025-02-14 |