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Olympus Endoscopic Flushing Pump Model OFP-1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000948

by Keymed (Medical & Industrial Equipment), Ltd.

Identifiers

510(k) Number
K000948 FDA 510(k)
FDA Product Code
FEQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Olympus Endoscopic Flushing Pump Model Ofp-1 is a pump, air, non-manual, for endoscope. It is used to wash the site being visualized during GI endoscopy, when blood, faeces or other organic matter obscure the endoscopic view. The system uses a peristaltic pump and associated tubing to control and direct irrigation water to the site.

The Olympus Endoscopic Flushing Pump Model Ofp-1 is supplied with a model number of Ofp-1. It has been given an FDA 510K authorization. The device is used in the medical specialty of Gastroenterology and Urology. The pump is designed to facilitate direct washing of debris from the observation site during GI endoscopic examinations.

Frequently asked questions

What is the Olympus Endoscopic Flushing Pump Model Ofp-1 used for?

The Olympus Endoscopic Flushing Pump Model Ofp-1 is used to wash the site being visualized during GI endoscopy, when blood, faeces or other organic matter obscure the endoscopic view.

How does the Olympus Endoscopic Flushing Pump Model Ofp-1 work?

The system uses a peristaltic pump and associated tubing to control and direct irrigation water to the site, facilitating direct washing of debris from the observation site during GI endoscopic examinations.

What medical specialties use the Olympus Endoscopic Flushing Pump Model Ofp-1?

The device is used in the medical specialties of Gastroenterology and Urology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Olympus Endoscopic Flushing Pump Model Ofp-1, OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 (K100803) — FDA 510 (k) | Innolitics, OLYMPUS OFP INSTRUCTIONS MANUAL Pdf Download | ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Keymed (Medical & Industrial Equipment), Ltd.

Sources (1)

  • FDA 510(k) K000948 24 fields · synced Oct 6, 2026