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510(k) K090583

ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 by Apollo Endosurgery, Inc. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2009
Date Received
March 4, 2009
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 Apollo Endosurgery, Inc.

  • K232544 — Apollo ESG NXT System, Apollo REVISE NXT System (September 18, 2023)
  • K231553 — OverStitch NXT Endoscopic Suturing System (June 29, 2023)
  • DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX (July 12, 2022)
  • K210266 — OverStitch Sx Endoscopic Suturing System (March 2, 2021)
  • K201808 — X-Tack Endoscopic HeliX Tacking System (December 15, 2020)
  • K191439 — OverStitch 2-0 Polypropylene Suture (August 29, 2019)
  • K181141 — OverStitch Endoscopic Suturing System and Accessories (June 27, 2018)
  • K171886 — OverStitch SX Endoscopic Suturing System (ESS) (November 15, 2017)
  • K122270 — OVERTUBE ENDOSCOPIC ACCESS SYSTEM (September 28, 2012)
  • K103155 — SUMO ACCESS AND TISSUE RESECTION SYSTEM (October 28, 2011)

Other clearances for product code KGE

  • K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (March 6, 2026)
  • K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (October 7, 2025)
  • K242857 — ClearHemograsper (May 21, 2025)
  • K231721 — Disposable Hot Biopsy Forceps (December 14, 2023)
  • 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)
  • K180134 — Ensizor Monopolar Endoscopic Scissors (June 29, 2018)