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Shaver Blade Set

by Arthrex, Inc.

510(k) K940075

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 NumberK940075 Date15 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  • Withdrawn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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a shaver blade set, classified as an arthroscope under product code HRX. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The shaver blade set is supplied as a single-use, sterile device intended for use in arthroscopic surgical procedures. It is designed for use with the standard, large-hub Arthrex shaver handpiece and can be inserted with the cutting window in the up or down position. Threads molded into the blade hubs allow locking onto bridge cannulas for improved maneuverability and fluid management. The device is authorized under FDA 510(k) clearance K940075.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Questions

AI-generated answers, 1 Oct 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 SHAVER BLADE SET used for?

    The SHAVER BLADE SET is intended for use in arthroscopic surgical procedures, functioning as a cutting component when attached to an arthroscope handpiece to remove tissue during joint surgery.

  • Is the SHAVER BLADE SET sterile and single-use?

    Yes, the device is supplied as a single-use, sterile device, meaning it is intended for one procedure only and must be discarded after use to prevent cross-contamination and ensure patient safety.

  • What equipment is the SHAVER BLADE SET compatible with?

    The SHAVER BLADE SET is designed for use with the standard, large-hub Arthrex shaver handpiece and features molded threads in the blade hubs that allow it to lock securely onto bridge cannulas for enhanced control and fluid management during surgery.

  • How is the SHAVER BLADE SET regulated and cleared for use?

    The SHAVER BLADE SET was cleared through the FDA’s traditional 510(k) pathway as a substantially equivalent device under product code HRX, with clearance granted under K940075 on April 15, 1994.