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510(k) K790872

ENTERIC TUBE GUIDE by Biosearch Medical Products, Inc. — Product Code FZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1979
Date Received
May 7, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K964871 — BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS (March 3, 1997)
  • K951260 — URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT (September 27, 1995)
  • K944614 — MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM (April 5, 1995)
  • K932295 — NON-BALLOON REPLACEMENT GASTROSTOMY KIT (September 8, 1994)
  • K935045 — BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER (August 19, 1994)
  • K923002 — ENTEROCLYSIS TUBE (June 28, 1994)
  • K934193 — CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST (November 19, 1993)
  • K922987 — LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC. (April 23, 1993)

Other clearances for product code FZX

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • K871413 — CIVCO STEPPER (July 14, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K862564 — A.C.L. GUIDE KIT (August 18, 1986)
  • K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (December 24, 1985)
  • K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER (July 11, 1985)
  • K842698 — BRITISH SPINAL FUSION SET (September 12, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841619 — DRILL GUIDE (July 11, 1984)
  • K841297 — TECHMEDICA DRILL GUIDE (April 25, 1984)