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Micro-Planer Handpiece

by Trebay Medical Corp.

510(k) K954715

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 NumberK954715 Date27 Oct 1995ClearedStatusActive

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  • Withdrawn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
ERL
Device Class
Class II
Regulation
21 CFR Part 874.4250
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Micro-Planer Handpiece is a surgical drill device classified under the Ear, Nose, Throat specialty. It is an electric or pneumatic surgical drill including a handpiece, intended for use in otolaryngology procedures. The device is designed for cutting and shaping tissue in the ear, nose, and throat region during surgical interventions.

This single-use device is supplied by Trebay Medical Corp. and is regulated under FDA product code ERL with device class 2. It received FDA 510(k) clearance under number K954715, with a decision of substantially equivalent made on October 27, 1995. The device is not MRI safe, and no specific storage conditions are detailed in the available data.

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Questions

AI-generated answers, 25 Sep 2026

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

  • What clinical applications is the Micro-Planer Handpiece intended for?

    It is designed for otolaryngology surgeries, specifically to cut and shape tissue in the ear, nose, and throat during operative procedures. Its function as a drill helps surgeons perform precise bone and soft‑tissue work in these anatomical regions.

  • Is the device supplied as a sterile, single‑use product?

    Yes, the Micro-Planer Handpiece is provided by Trebay Medical Corp. as a single‑use item. This means each handpiece is intended for one patient only and is discarded after the procedure, eliminating the need for re‑processing and reducing cross‑contamination risk.

  • What power options are available for this handpiece?

    The handpiece can operate on either electric or pneumatic power sources, giving clinicians flexibility to match the equipment available in their operating room. The choice of power does not affect its intended use for cutting and shaping ENT tissue.

  • Are there any special storage requirements or MRI safety concerns?

    The available data do not specify particular storage conditions, so standard clean, dry storage is recommended. The device is not MRI safe, meaning it should not be brought into the magnetic field of an MRI scanner.