SURGISEAL TWIST TOPICAL SKIN ADHESIVE
FDA 510(k) clearance K141215 · decided 2014-08-21
Clearance details
- K-number
- K141215
- Device name
- SURGISEAL TWIST TOPICAL SKIN ADHESIVE
- Applicant
- Adhezion Biomedical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-05-12
- Decision date
- 2014-08-21
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- MPN
- Device class
- 2
- Regulation number
- 878.4010
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wyomissing, PA, 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.
| Record | Firm | Date |
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| CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) (K250950) | Okapi Medical, LLC Dba Resivant Medical | 2025-08-04 |
| CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) (K234114) | Okapi Medical, LLC Dba Resivant Medical | 2024-08-20 |
| CM005 Standard (CM005); CM004 Mini (CM004) (K233458) | Connexicon Medical , Ltd. | 2024-07-15 |
| Meriglu Topical Skin Adhesive (K230981) | M/s. Meril Endo Surgery Private Limited. | 2024-03-16 |
| Exofin Precision Pen (K212246) | Chemence Medical, Inc. | 2021-09-09 |
| Exofin High Viscosity Topical Skin Adhesive (K200264) | Chemence Medical, Inc. | 2020-12-17 |
| LiquiBand Plus (K183570) | Advanced Medical Solutions Limited | 2020-03-09 |
| derma+flex QS High Viscosity Tissue Adhesive (K162352) | Chemence Medical, Inc. | 2016-12-22 |
| SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive (K161011) | Adhezion Biomedical, LLC | 2016-11-08 |
| ACTABOND Topical Skin Adhesive (K161050) | Bergen Medical Products, Inc. | 2016-10-04 |
| Exofin High Viscosity Tissue Adhesive (K152476) | Chemence Medical Products, Inc. | 2016-02-09 |
Recalls involving this device
No recalls on record reference this clearance.