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FDA 510(k)

SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive

K-Number: K161011 · 2016-11-08

ApplicantAdhezion Biomedical, LLC
Decision Date2016-11-08
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive is a medical device manufactured by Adhezion Biomedical, LLC. It received FDA 510(k) clearance on 2016-11-08 under approval number K161011. 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 SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive?

SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive is a medical device that received FDA 510(k) clearance on 2016-11-08. It is manufactured by Adhezion Biomedical, LLC. The 510(k) number is K161011.

When was SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive approved by the FDA?

SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive received FDA 510(k) clearance on 2016-11-08, under approval number K161011.

What company makes SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive?

SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive is manufactured by Adhezion Biomedical, LLC.

What is the FDA product code for SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive?

The FDA product code for SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive is MPN.

Other Devices by Adhezion Biomedical, LLC

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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.

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