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FDA 510(k), K182451, BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
FDA 510(k), K182451, BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
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$149.00 USD
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510(K) Number: K182451
Device Name: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Manufacturer: Rebecca Clark
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: 09/07/2018
Date Received: 11/06/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Manufacturer: Rebecca Clark
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: 09/07/2018
Date Received: 11/06/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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