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Hmt Alexcope

by Servicetrends, Inc.

510(k) K941013

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

Overview

The HMT Alexcope is a high-quality ureteroscope and accessories designed for minimally invasive urological procedures. This device is substantially equivalent to the existing market, meeting stringent regulatory standards.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941013 Date9 Feb 1995ClearedStatusActive

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  • Withdrawn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
FGB
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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