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510(k) K210406

Bipolar Coagulation Foreceps by Hangzhou AGS MedTech Co., Ltd. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2021
Date Received
February 10, 2021
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 Hangzhou AGS MedTech Co., Ltd.

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  • K241704 — Endoscopic Water Pump (March 20, 2025)
  • K222421 — Sphincterotome (May 3, 2023)
  • K221713 — Polypectomy Snare (March 3, 2023)
  • K213143 — Hemoclip (July 12, 2022)
  • K213578 — Balloon Dilatation Catheter (April 6, 2022)
  • K211787 — Hemoclip (March 3, 2022)
  • K201121 — Sphincterotome (February 5, 2021)
  • K202237 — Locking device (December 23, 2020)
  • K201509 — Disposable Stone Extraction basket (December 16, 2020)

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)
  • 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)
  • K171973 — Captura® Disposable Hot Biopsy Forceps (March 21, 2018)