derma+flex QS High Viscosity Tissue Adhesive
FDA 510(k) K162352 · Chemence Medical, Inc.
510(k) numberK162352
Submission
- Device name
- derma+flex QS High Viscosity Tissue Adhesive
- Applicant
- Chemence Medical, Inc.
Alpharetta, GA, US - Received
- August 23, 2016
- Decision date
- December 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MPN – Tissue Adhesive For The Topical Approximation Of Skin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4010
- Specialty
- General, Plastic Surgery
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Other 510(k)s with product code MPN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243990 | BondEase 2 Topical Skin AdhesiveMPN · Traditional | Optmed, Inc. | 09/19/2025SE |
| K250950 | CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739)MPN · Traditional | Okapi Medical, LLC Dba Resivant Medical | 08/04/2025SE |
| K234114 | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)MPN · Traditional | Okapi Medical, LLC Dba Resivant Medical | 08/20/2024SE |
| K233458 | CM005 Standard (CM005); CM004 Mini (CM004)MPN · Traditional | Connexicon Medical , Ltd. | 07/15/2024SE |
| K230981 | Meriglu Topical Skin AdhesiveMPN · Traditional | M/s. Meril Endo Surgery Private Limited. | 03/16/2024SE |
| K212246 | Exofin Precision PenMPN · Special | Chemence Medical, Inc. | 09/09/2021SE |
| K200264 | Exofin High Viscosity Topical Skin AdhesiveMPN · Traditional | Chemence Medical, Inc. | 12/17/2020SE |
| K183570 | LiquiBand PlusMPN · Traditional | Advanced Medical Solutions Limited | 03/09/2020SE |
| K161011 | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist…MPN · Traditional | Adhezion Biomedical, LLC | 11/08/2016SE |
| K161050 | ACTABOND Topical Skin AdhesiveMPN · Traditional | Bergen Medical Products, Inc. | 10/04/2016SE |
More from Bergen Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212246 | Exofin Precision PenMPN · Special | 09/09/2021SE |
| K200264 | Exofin High Viscosity Topical Skin AdhesiveMPN · Traditional | 12/17/2020SE |
| K191461 | Exofin Fusion Skin Closure SystemOMD · Traditional | 06/05/2020SE |
| K171442 | Exofin Fusion Skin Closure SystemOMD · Abbreviated | 09/25/2017SE |
| K050757 | Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive Professional Liquid BandageKMF · Traditional | 02/23/2006SE |
Questions and answers
When was derma+flex QS High Viscosity Tissue Adhesive cleared by the FDA?
derma+flex QS High Viscosity Tissue Adhesive (K162352) received a 510(k) decision of Substantially Equivalent on December 22, 2016, 121 days after the submission was received.
What is the product code of K162352?
The FDA product code is MPN – Tissue Adhesive For The Topical Approximation Of Skin, a Class II (moderate risk) device regulated under 21 CFR 878.4010.