Retraxil
K-Number: K243910 · 2025-09-24
Device Summary
Retraxil is a medical device manufactured by Kulzer, LLC. It received FDA 510(k) clearance on 2025-09-24 under approval number K243910. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Retraxil?
Retraxil is a medical device that received FDA 510(k) clearance on 2025-09-24. It is manufactured by Kulzer, LLC. The 510(k) number is K243910.
When was Retraxil approved by the FDA?
Retraxil received FDA 510(k) clearance on 2025-09-24, under approval number K243910.
What company makes Retraxil?
Retraxil is manufactured by Kulzer, LLC.
What is the FDA product code for Retraxil?
The FDA product code for Retraxil is MVL.
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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.