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FDA 510(k)

OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2

K-Number: K100899 · 2010-09-13

ApplicantKeymed (Medical & Industrial Equipment), Ltd.
Decision Date2010-09-13
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 is the device name listed in this FDA 510(k) record. The listed applicant is Keymed (Medical & Industrial Equipment), Ltd.. It received FDA 510(k) clearance on 2010-09-13 under 510(k) number K100899. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2?

OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 is a medical device that received FDA 510(k) clearance on 2010-09-13. The listed applicant is Keymed (Medical & Industrial Equipment), Ltd.. The 510(k) number is K100899.

When did OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 receive FDA 510(k) clearance?

OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 received FDA 510(k) clearance on 2010-09-13, under 510(k) number K100899.

Who is the listed applicant for OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2?

The FDA 510(k) record lists Keymed (Medical & Industrial Equipment), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2?

The FDA product code for OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 is FEQ.

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Other records listing Keymed (Medical & Industrial Equipment), Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193250Irrigation Tubing with CO2 or AirK011725OLYMPUS SUCTION PUMP, MODEL KV-5K000948OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1K962528OLYMPUS MOBILE CHAIR/COUCHK930852OLYMPUS SUCTION PUMP MODEL KV-4K881478MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

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Related Devices (Code: FEQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220395EndoGator Endoscopy Irrigation TubingSTERIS CorporationK191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States Endoscopy Group, Inc.K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc.K173650AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc.K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONUnited State Endoscopy Group, Inc.K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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