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510(k) K100899

OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 by Keymed (Medical & Industrial Equipment), Ltd. — Product Code FEQ

K100899 is an FDA 510(k) premarket notification submitted by Keymed (Medical & Industrial Equipment), Ltd. for the device "OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2". The FDA issued a decision of Substantially Equivalent on September 13, 2010. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Keymed (Medical & Industrial Equipment), Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2010
Date Received
March 31, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Air, Non-Manual, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Keymed (Medical & Industrial Equipment), Ltd.

  • K193250 — Irrigation Tubing with CO2 or Air (April 6, 2020)
  • K011725 — OLYMPUS SUCTION PUMP, MODEL KV-5 (August 31, 2001)
  • K000948 — OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 (May 12, 2000)
  • K962528 — OLYMPUS MOBILE CHAIR/COUCH (December 12, 1996)
  • K930852 — OLYMPUS SUCTION PUMP MODEL KV-4 (March 31, 1994)
  • K881478 — MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS (September 14, 1988)

Other clearances for product code FEQ

  • K220395 — EndoGator Endoscopy Irrigation Tubing (March 11, 2022)
  • K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIF (August 1, 2019)
  • K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - (September 21, 2018)
  • K173650 — AquaShield System CO2- Fujifilm (January 5, 2018)
  • K163424 — AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO (January 4, 2017)
  • K162152 — Erbe’s CO2 Tubing/Cap Sets (August 31, 2016)
  • K161482 — EndoChoice Water Bottle Cap Irrigation System (June 27, 2016)
  • K153588 — EndoChoice Water Bottle Cap System (February 24, 2016)
  • K153362 — AquaShield system CO2, AquaShield system-PENTAX (December 16, 2015)
  • K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM (January 20, 2015)

FDA data resources