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510(k) K180134

Ensizor Monopolar Endoscopic Scissors by Slater Endoscopy, LLC — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2018
Date Received
January 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Electric
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Slater Endoscopy, LLC

  • K150939 — Ensizor Endoscopic Scissors (June 8, 2015)
  • K141058 — ENSIZOR ENDOSCOPIC SCISSORS (August 1, 2014)

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  • K220053 — Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI (February 4, 2022)
  • K210406 — Bipolar Coagulation Foreceps (October 5, 2021)
  • K202438 — Ensure Single-Use Coagulation Forceps (March 15, 2021)
  • K183428 — Avulsion Forceps (April 16, 2019)
  • K180018 — Disposable Hot Biopsy Forceps (July 5, 2018)
  • K171973 — Captura® Disposable Hot Biopsy Forceps (March 21, 2018)