PINNACLE PELVIC FLOOR REPAIR KIT II
FDA 510(k) clearance K081048 · decided 2008-08-22
Clearance details
- K-number
- K081048
- Device name
- PINNACLE PELVIC FLOOR REPAIR KIT II
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2008-04-14
- Decision date
- 2008-08-22
- Days to decision
- 130 days
- Clearance type
- Abbreviated
- Product code
- OTP
- Device class
- 3
- Regulation number
- 884.5980
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in w recall (Z-1626-2018) | Boston Scientific Corporation | 2018-05-04 |