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Navigator Endoscopy System

by Neoguide Systems, Inc.

510(k) K052930

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052930 Date31 Jan 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FDF
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Navigator Endoscopy System is a device intended to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract, including the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve for endoscopy and endoscopic surgery. The system includes a console with video, light, and insufflation functions, and motors controlling segments in the insertion tube.

The Navigator Endoscopy System is a reusable device classified under product code FDF with FDA 510(k) clearance K052930, received on 2005-10-19 and deemed substantially equivalent on 2006-01-31. It is regulated under 876.1500 and intended for use in gastroenterology and urology specialties. The device is supplied as a complete system with various model numbers and registration numbers as specified in the device data.

Other devices from Neoguide Systems, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Navigator Endoscopy System used for?

    The Navigator Endoscopy System is designed to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract, including the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve for endoscopy and endoscopic surgery.

  • Is the Navigator Endoscopy System reusable or single-use?

    The Navigator Endoscopy System is a reusable device that can be used multiple times after proper cleaning and sterilization according to the manufacturer's instructions.

  • What components are included in the Navigator Endoscopy System?

    The system includes a console with video, light, and insufflation functions, and motors controlling segments in the insertion tube. It is supplied as a complete system with various model numbers and registration numbers.

  • What regulatory clearance does the Navigator Endoscopy System have?

    The Navigator Endoscopy System has FDA 510(k) clearance K052930, received on 2005-10-19 and deemed substantially equivalent on 2006-01-31. It is classified under product code FDF and regulated under 876.1500.