DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
FDA 510(k) clearance K120284 · decided 2012-05-23
Clearance details
- K-number
- K120284
- Device name
- DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 2012-01-31
- Decision date
- 2012-05-23
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- NEW
- Device class
- 2
- Regulation number
- 878.4840
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031 recall (Z-1486-2013) | Coloplast Manufacturing US, LLC | 2013-06-05 |