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Acu Med, Inc.

by Acu Med, Inc.

510(k) K963026

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 NumberK963026 Date28 Oct 1996ClearedStatusActive

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  • Withdrawn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
Tbd
510(k) Number
FDA product code
HSB
Device class
Class II
Regulation
21 CFR Part 888.3020
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 TBD is a medical device manufactured by Acu Med, Inc. It falls under the product code HSB, which is associated with orthopedic devices. The device has received FDA 510(k) clearance with the decision code SESE, indicating it is substantially equivalent to other devices on the market.

The TBD is supplied by Acu Med, Inc. located in Beaverton, Oregon. The device received FDA clearance on October 28, 1996, with the K-number K963026. No specific information regarding sterility, single-use or reusable status, MRI safety, or sizes is provided in the device data.

Other devices from Acumed LLC

See all devices from Acumed LLC →

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 TBD medical device used for?

    The TBD is an orthopedic medical device that has received FDA 510(k) clearance with decision code SESE, indicating it is substantially equivalent to other devices on the market. However, specific indications or uses are not provided in the available device data.

  • Is the TBD device sterile and single-use or reusable?

    The available device data does not specify whether the TBD is supplied sterile or if it is designed for single-use or multiple reuse. This information would need to be obtained directly from the manufacturer, Acu Med, Inc., or through the product's labeling and instructions for use.

  • What sizes and models of the TBD are available?

    No information regarding specific sizes, models, or configurations of the TBD device is provided in the device data. The manufacturer may offer different variants, but this detail is not included in the regulatory information available.

  • How should the TBD device be stored?

    The device data does not include specific storage instructions for the TBD. Proper storage conditions would typically be outlined in the product's instructions for use, which should be consulted for guidance on temperature, humidity, and other environmental factors.