FDA 510(k), K123212, ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS

FDA 510(k), K123212, ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS

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510(K) Number: K123212
Device Name: ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
Manufacturer: ETHICON ENDO-SURGERY, LLC
Device Classification Name: electrosurgical vessel and/or tissue sealer. with built-in generator.
Regulation Number: 878.4400
Classification Product Code: PDG
Date Received: 10/15/2012
Decision Date: 03/08/2013
Regulation Medical Specialty: General & Plastic Surgery
  • 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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