GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
FDA 510(k) clearance K874690 · decided 1988-02-08
Clearance details
- K-number
- K874690
- Device name
- GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
- Applicant
- Mentor Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-16
- Decision date
- 1988-02-08
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FFX
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MENTOR MemoryGel Breast Implants (P030053/S085) | Mentor Corp. | 2026-07-21 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S083) | Mentor Corp. | 2026-05-11 |
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S089) | Mentor Corp. | 2026-05-01 |
| MemoryGel Silicone Gel-Filled Breast Implant (P030053/S088) | Mentor Corp. | 2026-04-30 |
| MENTOR MemoryGel Breast Implants (P030053/S087) | Mentor Corp. | 2026-02-04 |
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S086) | Mentor Corp. | 2026-01-02 |
| 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 |