Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

derma+flex QS High Viscosity Tissue Adhesive

K-Number: K162352 · 2016-12-22

ApplicantChemence Medical, Inc.
Decision Date2016-12-22
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

derma+flex QS High Viscosity Tissue Adhesive is a medical device manufactured by Chemence Medical, Inc.. It received FDA 510(k) clearance on 2016-12-22 under approval number K162352. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the derma+flex QS High Viscosity Tissue Adhesive?

derma+flex QS High Viscosity Tissue Adhesive is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Chemence Medical, Inc.. The 510(k) number is K162352.

When was derma+flex QS High Viscosity Tissue Adhesive approved by the FDA?

derma+flex QS High Viscosity Tissue Adhesive received FDA 510(k) clearance on 2016-12-22, under approval number K162352.

What company makes derma+flex QS High Viscosity Tissue Adhesive?

derma+flex QS High Viscosity Tissue Adhesive is manufactured by Chemence Medical, Inc..

What is the FDA product code for derma+flex QS High Viscosity Tissue Adhesive?

The FDA product code for derma+flex QS High Viscosity Tissue Adhesive is MPN.

Related Clinical Trials

NCT07530419 Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD) NOT_YET_RECRUITING NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

Other Devices by Chemence Medical, Inc.

K171442Exofin Fusion Skin Closure System K200264Exofin High Viscosity Topical Skin Adhesive K191461Exofin Fusion Skin Closure System K212246Exofin Precision Pen

Related Devices (Code: MPN)

K161011SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin AdhesiveAdhezion Biomedical, LLC K161050ACTABOND Topical Skin AdhesiveBergen Medical Products, Inc. K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. K150032GluStitch Twist Tissue AdhesiveGlustitch, Inc. K200264Exofin High Viscosity Topical Skin AdhesiveChemence Medical, Inc. K183570LiquiBand PlusAdvanced Medical Solutions Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑