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Full 510(k) Record – K231325 (with AI requests & Amendments, StimLabs)
Full 510(k) Record – K231325 (with AI requests & Amendments, StimLabs)
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510(K) Number: K231325
Device Name: Corplex P / Theracor P / Allacor P
Manufacturer: StimLabs, LLC
Device Classification Name: Wound Dressing With Animal-Derived Material(S)
Regulation Number:
Classification Product Code: KGN
Date Received: 05/08/2023
Decision Date: 02/02/2024
Regulation Medical Specialty:
Request Contents: Full 510(k) record of K231325, including Additional Information (AI) requests, responses, correspondence from StimLabs, LLC. and its agents to the FDA, and any releasable amendments.
Device Name: Corplex P / Theracor P / Allacor P
Manufacturer: StimLabs, LLC
Device Classification Name: Wound Dressing With Animal-Derived Material(S)
Regulation Number:
Classification Product Code: KGN
Date Received: 05/08/2023
Decision Date: 02/02/2024
Regulation Medical Specialty:
Request Contents: Full 510(k) record of K231325, including Additional Information (AI) requests, responses, correspondence from StimLabs, LLC. and its agents to the FDA, and any releasable amendments.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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