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510(k) K941359

GIP/MEDI-GLOBE BIOPSY FORCEPS by Medi-Globe Corp. — Product Code FCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1994
Date Received
March 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Non-Electric
Device Class
Class I
Regulation Number
876.1075
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)
  • K953355 — GIP/MEID-GLOBE HOT BIOPSY FORCEPS (April 4, 1996)
  • 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)

Other clearances for product code FCL

  • K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
  • K973611 — SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (December 2, 1997)
  • K971315 — AUXILIARY INSTRUMENTS FOR URS (September 15, 1997)
  • K964120 — INJECTO FLUSH (December 30, 1996)
  • K963517 — SPECTRA SCIENCE BIOPSY FORCEPS (December 2, 1996)
  • K955065 — OLYMPUS FB SERIES BIOPSY FORCEPS (January 24, 1996)
  • K952863 — FORCEPS, BIOPSY, NON-ELECTRIC (July 19, 1995)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)
  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)