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Flexible Endoscopic Electrodes

by North American Sterilization & Packaging Co.

510(k) K903162

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 NumberK903162 Date18 Dec 1990ClearedStatusActive

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  • Withdrawn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
FAS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Flexible Endoscopic Electrodes are active electrosurgical electrodes designed for use through an endoscope in gastroenterology and urology procedures. They deliver high‑frequency electrical energy to cut, coagulate, or ablate tissue during endoscopic interventions. The device is classified as an Electrode, Electrosurgical, Active, Urological according to the FDA nomenclature.

The electrodes were cleared through an FDA 510(k) submission (K903162) and are assigned product code FAS, class II, regulated under 21 CFR 876.4300. They are supplied by North American Sterilization & Packaging Co. and are intended for single‑use or reusable application as specified by the purchaser, with no additional sterility or packaging details provided in the data.

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