PRINEO SKIN CLOSURE SYSTEM
FDA 510(k) clearance DEN090005 · decided 2010-04-30
Clearance details
- K-number
- DEN090005
- Device name
- PRINEO SKIN CLOSURE SYSTEM
- Applicant
- Closure Medical Corp.
- Decision
- Unknown
- Date received
- 2009-03-24
- Decision date
- 2010-04-30
- Days to decision
- 402 days
- Clearance type
- Post-NSE
- Product code
- OMD
- Device class
- 2
- Regulation number
- 878.4011
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Raleigh, NC, 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 |
|---|---|---|
| CM00622 LINC Skin Closure System (CM00622 LINC) (K233460) | Connexicon Medical , Ltd. | 2024-07-15 |
| LiquiBand XL (K211878) | Advanced Medical Solutions Limited | 2022-05-23 |
| DERMABOND PRINEO Skin Closure System (K213512) | ETHICON, Inc. | 2021-12-07 |
| Exofin Fusion Skin Closure System (K191461) | Chemence Medical, Inc. | 2020-06-05 |
| Exofin Fusion Skin Closure System (K171442) | Chemence Medical, Inc. | 2017-09-25 |
| DERMABOND PRINEO Skin Closure System (K163645) | Ethicon, LLC | 2017-04-21 |
| DERMABOND PRINEO Skin Closure System (K152490) | ETHICON, Inc. | 2015-11-25 |
| DERMABOND PRINEO SKIN CLOSURE SYSTEM (K133864) | ETHICON, Inc. | 2014-03-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S012) | Closure Medical Corp. | 2006-09-14 |
| HIGH VISCOSITY DERMABOND MINI APPLICATOR (P960052/S011) | Closure Medical Corp. | 2006-02-10 |
| HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE (P960052/S010) | Closure Medical Corp. | 2005-03-21 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S009) | Closure Medical Corp. | 2004-09-24 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S007) | Closure Medical Corp. | 2003-12-01 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S006) | Closure Medical Corp. | 2003-06-13 |
| DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY (P960052/S004) | Closure Medical Corp. | 2002-12-31 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S005) | Closure Medical Corp. | 2002-07-24 |