MENTOR PATHWAY INTRODUCER/DILATOR
FDA 510(k) clearance K981527 · decided 1998-07-09
Clearance details
- K-number
- K981527
- Device name
- MENTOR PATHWAY INTRODUCER/DILATOR
- Applicant
- Mentor Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-28
- Decision date
- 1998-07-09
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- QPB
- Device class
- 2
- Regulation number
- 878.5040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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No recalls on record reference this clearance.
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|---|---|---|
| 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 |
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| Mentor MemoryGel® Breast Implants (P030053/S072) | Mentor Corp. | 2025-08-06 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S077) | Mentor Corp. | 2025-07-03 |
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