SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
FDA 510(k) clearance K131229 · decided 2013-12-05
Clearance details
- K-number
- K131229
- Device name
- SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
- Applicant
- American Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2013-04-30
- Decision date
- 2013-12-05
- Days to decision
- 219 days
- Clearance type
- Special
- Product code
- OTN
- 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfa recall (Z-0805-2015) | American Medical Systems, Inc. | 2014-12-16 |