PINNACLE PELVIC FLOOR REPAIR KITS
FDA 510(k) clearance K071957 · decided 2007-11-08
Clearance details
- K-number
- K071957
- Device name
- PINNACLE PELVIC FLOOR REPAIR KITS
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2007-07-16
- Decision date
- 2007-11-08
- Days to decision
- 115 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
+ Add to Predicate Builder ◉ Watch Boston Scientific Corp
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement recall (Z-1624-2018) | Boston Scientific Corporation | 2018-05-04 |
| PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in wo recall (Z-1625-2018) | Boston Scientific Corporation | 2018-05-04 |
| Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repai recall (Z-2931-2011) | Boston Scientific Corporation | 2011-08-03 |