BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
K-Number: K242146 · 2024-12-17
ApplicantSmith & Nephew Medical Limited
Decision Date2024-12-17
Product CodeKGN
DecisionSubstantially Equivalent
Device Summary
BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2024-12-17 under approval number K242146. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?
BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is a medical device that received FDA 510(k) clearance on 2024-12-17. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K242146.
When was BIOBRANE Temporary Wound Dressing; BIOBRANE Glove approved by the FDA?
BIOBRANE Temporary Wound Dressing; BIOBRANE Glove received FDA 510(k) clearance on 2024-12-17, under approval number K242146.
What company makes BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?
BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is manufactured by Smith & Nephew Medical Limited.
What is the FDA product code for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?
The FDA product code for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is KGN.
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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.