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510(k) K964871

BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS by Biosearch Medical Products, Inc. — Product Code FEB

K964871 is an FDA 510(k) premarket notification submitted by Biosearch Medical Products, Inc. for the device "BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on March 3, 1997. The device falls under product code FEB (Accessories, Cleaning, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Biosearch Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1997
Date Received
December 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Cleaning, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
  • 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)
  • K923474 — LOW PROFILE GASTROMSTOMY DEVICE (January 5, 1993)

Other clearances for product code FEB

  • K241168 — System 83 Revolve Endoscope Washer/Disinfector (December 19, 2024)
  • K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (December 2, 2024)
  • K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (June 30, 2023)
  • K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid (January 14, 2022)
  • K201920 — Endoscope Reprocessor OER-Elite (September 1, 2020)
  • K173590 — System 83 Plus Washer/Disinfector (March 30, 2020)
  • K190969 — ENDOSCOPE REPROCESSOR OER-Elite (July 9, 2019)
  • K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (April 23, 2019)
  • K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System (December 14, 2018)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)

FDA data resources