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FDA 510(k), K123601, SINGLE USE REPOSITIONABLE CLIP
FDA 510(k), K123601, SINGLE USE REPOSITIONABLE CLIP
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510(K) Number: K123601
Device Name: SINGLE USE REPOSITIONABLE CLIP
Manufacturer: SHERI L MUSGNUNG
Device Classification Name: Hemostatic Metal Clip For The Gi Tract
Regulation Number: PKL
Classification Product Code: KXA
Date Received: 11/21/2012
Decision Date: 04/29/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SINGLE USE REPOSITIONABLE CLIP
Manufacturer: SHERI L MUSGNUNG
Device Classification Name: Hemostatic Metal Clip For The Gi Tract
Regulation Number: PKL
Classification Product Code: KXA
Date Received: 11/21/2012
Decision Date: 04/29/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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