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Acufex Arthroscopic Suture Cutter

by Acufex Microsurgical, Inc.

510(k) K940506

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 NumberK940506 Date26 Apr 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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
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 Arthroscopic Suture Cutter is a specialized arthroscopic device classified as a suture cutting instrument (HRX product code). It is designed for precise, controlled cutting of sutures during arthroscopic procedures, enabling surgeons to perform delicate tissue repairs within confined joint spaces with minimal invasiveness.

This device is supplied sterile for single-use and is intended for use in orthopedic arthroscopic surgeries. It is cleared by the FDA under 510(k) (K940506) as substantially equivalent to a predicate device, with no third-party review. The instrument is manufactured by Acufex Microsurgical, Inc., and its design prioritizes precision in constrained surgical environments.

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