LTM-LABAROSCOPIC SURGICAL MESH
FDA 510(k) clearance K121289 · decided 2012-08-03
Clearance details
- K-number
- K121289
- Device name
- LTM-LABAROSCOPIC SURGICAL MESH
- Applicant
- Lifecell Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-30
- Decision date
- 2012-08-03
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- OXK
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LTN - LAPAROSCOPIC SURGICAL MESH (K130817) | Lifecell Corp. | 2013-04-17 |
Recalls involving this device
No recalls on record reference this clearance.