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Modified Endoguide

by Luxar Corp. 2 variants

510(k) K893642

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 NumberK893642 Date14 Jul 1989ClearedStatusActive

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  • Withdrawn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, 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 Modified Endoguide is a Class 2 medical device intended for use in general and plastic surgery procedures. It functions as a guide to assist the placement and manipulation of surgical instruments within the operative field.

The device is manufactured by Luxar Corp. and was cleared through the traditional FDA 510(k) pathway (decision date July 14 1989, decision code SESE, K‑number K893642) under product code GEX. It is identified as a single‑use, sterile device supplied by the manufacturer for use in the United States.

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