Skip to content

ETB Telescope w/Working Channel for SEPS

by The Altomec Corp.

510(k) K972298

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 NumberK972298 Date30 Jan 1998ClearedStatusActive

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  • Withdrawn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.

The ETB Telescope w/Working Channel for SEPS is an endoscopic instrument designed for subfascial endoscopic perforator surgery (SEPS) and fasciotomy. It functions as a telescope equipped with an outer sheath and a working channel, intended for use in natural or artificial body cavities to illuminate and facilitate endoscopic procedures.

The device is supplied as a reusable endoscopic instrument and was cleared via the FDA 510(k) pathway under K972298. It is classified under product code GCJ and was reviewed by the Gastroenterology and Urology advisory committees. The device is manufactured by The Altomec Corp. and received FDA clearance on January 30, 1998.

Other devices from The Altomec Corp.