DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
FDA 510(k) clearance K093112 · decided 2010-02-01
Clearance details
- K-number
- K093112
- Device name
- DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
- Applicant
- Coloplast Manufacturing Us, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-10-01
- Decision date
- 2010-02-01
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- GAW
- Device class
- 2
- Regulation number
- 878.5010
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| APTOS Threads – Polypropylene Surgical Sutures (K192953) | Aptos, LLC | 2020-08-27 |
| Deklene MAXX (K193530) | Teleflex Medical | 2020-03-19 |
| Silhouette Featherlift / Silhouette Lift (K191299) | Silhouette Lift, Inc. | 2019-06-14 |
| REXLENE (K173747) | Sm Eng Co., Ltd. | 2018-12-21 |
| Aesculap Optilene Nonabsorbable Suture (K180321) | Aesculap, Inc. | 2018-03-07 |
| Gazelle Polypropylene Suture and Delivery Device (K173644) | Dura Tap, LLC | 2018-02-15 |
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Recalls involving this device
No recalls on record reference this clearance.