Retraxil
K-Number: K243910 · 2025-09-24
Device Summary
Frequently Asked Questions
What is the Retraxil?
Retraxil is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Kulzer, LLC. The 510(k) number is K243910.
When did Retraxil receive FDA 510(k) clearance?
Retraxil received FDA 510(k) clearance on 2025-09-24, under 510(k) number K243910.
Who is the listed applicant for Retraxil?
The FDA 510(k) record lists Kulzer, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Retraxil?
The FDA product code for Retraxil is MVL.
Other records listing Kulzer, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MVL)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.