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Endo I/A Probe

by Snowden-Pencer

510(k) K924149

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 NumberK924149 Date26 Jan 1993ClearedStatusActive

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  • Withdrawn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
GCJ
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.

An endo I/A probe is a device used for irrigation and aspiration during endoscopic procedures. It is designed to deliver fluid and remove debris or fluids from body cavities.

This device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization. It is used in gastroenterology and urology settings, with authorization via FDA 510(k) clearance under product code GCJ.

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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 ENDO I/A PROBE used for?

    The ENDO I/A PROBE is used for irrigation and aspiration during endoscopic procedures to deliver fluid and remove debris or fluids from body cavities, specifically in gastroenterology and urology settings.

  • How is the ENDO I/A PROBE supplied and is it reusable?

    The ENDO I/A PROBE is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization, as stated in the device description.

  • What regulatory pathway was used for the ENDO I/A PROBE?

    The ENDO I/A PROBE received authorization via FDA 510(k) clearance, as indicated in the AUTHORIZATIONS field and confirmed by the decision_type and k_number.