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510(k) K953355

GIP/MEID-GLOBE HOT BIOPSY FORCEPS by Medi-Globe Corp. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1996
Date Received
July 17, 1995
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 Medi-Globe Corp.

  • K061222 — INJECTRA INJECTION NEEDLE (July 3, 2006)
  • K051247 — SONOTIP II ULTRASOUND NEEDLE SYSTEM (June 16, 2005)
  • K011261 — STONE EXTRACTOR BALLOON CATHETER (November 17, 2003)
  • K010714 — EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 (January 21, 2003)
  • K010549 — BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) (January 18, 2002)
  • K990220 — MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM (March 31, 1999)
  • K955558 — GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES (February 29, 1996)
  • K953827 — GIP/MEDI-GLOBE ERCP CATHETERS (September 1, 1995)
  • K941973 — GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES (June 30, 1995)
  • K943935 — GIP/MEDI-GLOBE POLYPECTOMY SNARES (May 26, 1995)

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)