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Alexantriptor

by Servicetrends, Inc.

510(k) K940461

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 NumberK940461 Date2 Jun 1994ClearedStatusActive

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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
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.

ALEXANTRIPTOR is a device classified under product code GEX, which corresponds to general and plastic surgery devices. It received FDA 510(k) clearance as substantially equivalent to a predicate device through a traditional review process.

The device was manufactured by Servicetrends, Inc. and received clearance on June 2, 1994, under K940461. It is authorized for distribution in the United States and is identified by the applicant and manufacturer details on file with the FDA.

Other devices from Servicetrends, Inc.

Questions

AI-generated answers, 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.

  • What is the ALEXANTRIPTOR device used for?

    The ALEXANTRIPTOR is classified under product code GEX, which corresponds to general and plastic surgery devices, indicating its intended use in those surgical specialties based on its FDA 510(k) clearance as substantially equivalent to a predicate device.

  • How was the ALEXANTRIPTOR cleared for market distribution?

    The ALEXANTRIPTOR received FDA 510(k) clearance through a traditional review process, determined to be substantially equivalent to a predicate device, which allowed it to be authorized for distribution in the United States under K940461.

  • Who manufactures the ALEXANTRIPTOR and where is it authorized for distribution?

    The ALEXANTRIPTOR is manufactured by Servicetrends, Inc., located in Kennesaw, Georgia, and is authorized for distribution in the United States, as confirmed by its FDA 510(k) clearance and manufacturer details on file.