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FDA 510(k), K210851, DiLumen Endolumenal Interventional Platform (DiLumen)
FDA 510(k), K210851, DiLumen Endolumenal Interventional Platform (DiLumen)
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510(K) Number: K210851
Device Name: DiLumen Endolumenal Interventional Platform (DiLumen)
Manufacturer: Dennis Daniels
Device Classification Name: Colonoscope And Accessories, Flexible/Rigid
Regulation Number: FDF
Classification Product Code: KXA
Date Received: 03/22/2021
Decision Date: 04/21/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DiLumen Endolumenal Interventional Platform (DiLumen)
Manufacturer: Dennis Daniels
Device Classification Name: Colonoscope And Accessories, Flexible/Rigid
Regulation Number: FDF
Classification Product Code: KXA
Date Received: 03/22/2021
Decision Date: 04/21/2021
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
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