MENTOR SELF-CATH PLUS
FDA 510(k) clearance K003784 · decided 2001-03-05
Clearance details
- K-number
- K003784
- Device name
- MENTOR SELF-CATH PLUS
- Applicant
- Mentor Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-07
- Decision date
- 2001-03-05
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Barbara, CA, 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 |
|---|---|---|
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S084) | Mentor Corp. | 2025-12-17 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S080) | Mentor Corp. | 2025-08-12 |
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S082) | Mentor Corp. | 2025-08-08 |
| Mentor MemoryGel® Breast Implants (P030053/S072) | Mentor Corp. | 2025-08-06 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S077) | Mentor Corp. | 2025-07-03 |
| 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 |