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510(k) K914497

BIOPSY FORCEPS by Surgitek Medical Engineering Corp. — Product Code FCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1992
Date Received
October 8, 1991
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 Surgitek Medical Engineering Corp.

  • K914504 — CYTOLOGY BRUSH (February 18, 1992)
  • K914495 — E.R.C.P. CATHETER (January 30, 1992)
  • K914505 — STONE BASKET (December 9, 1991)
  • K914496 — SCLEROTHERAPY NEEDLE (December 5, 1991)
  • K914503 — GRASPING FORCEPS (December 5, 1991)
  • K913928 — SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT (November 19, 1991)
  • K913294 — SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT (October 4, 1991)
  • K910769 — SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM (June 25, 1991)
  • K910768 — SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE (March 19, 1991)
  • K903127 — SURGITEK(R) TURP MONITOR (October 9, 1990)

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)