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Acufex Tag

by Acufex Microsurgical, Inc.

510(k) K911293

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 NumberK911293 Date21 Jul 1993ClearedStatusActive

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  • Withdrawn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)

Full name
Acufex(R) Tag(Tm)
510(k) Number
FDA Product Code
JDR
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Acufex Tag is a surgical tag, classified under product code JDR, designed for orthopedic applications. It is intended for marking or identifying anatomical structures or implants during surgical procedures to enhance precision and reduce errors.

This device is supplied as a reusable surgical instrument and is cleared under the FDA 510(k) pathway with K-number K911293. It was granted Substantially Equivalent status by the Orthopedic (OR) Advisory Committee in 1993 and is manufactured by Acufex Microsurgical, Inc. No additional regulatory or sterility details are specified in the provided data.

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