MINIARC PRO SINGLE-INCISION SLING SYSTEM
FDA 510(k) clearance K121641 · decided 2012-09-07
Clearance details
- K-number
- K121641
- Device name
- MINIARC PRO SINGLE-INCISION SLING SYSTEM
- Applicant
- American Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2012-06-04
- Decision date
- 2012-09-07
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- PAH
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch American Medical Systems
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 |
|---|---|---|
| MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 93 recall (Z-0279-2016) | Astora | 2015-11-16 |