Home / 510(k) Clearances / K914482

510(k) K914482

STOMA MEASURING DEVICE by Biosearch Medical Products, Inc. — Product Code FPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1991
Date Received
October 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Biosearch Medical Products, Inc.

  • K051480 — ENTERAL FEEDING TUBE (October 12, 2005)
  • K970145 — PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) (August 11, 1997)
  • 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 FPD

  • K243361 — Nutrifit (December 19, 2024)
  • K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (January 18, 2019)
  • K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (October 23, 2013)
  • K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (March 6, 2013)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • K110853 — VR MEDICAL ENTERAL ORAL SYRINGE (May 13, 2011)
  • K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (December 13, 2010)
  • K101214 — GUARDIAN CONNECTION (July 23, 2010)
  • K100099 — ORAL/ENTERAL SYRINGES (June 14, 2010)