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Poly/Platinum Wire Piston

by Micromed Development Corp.

510(k) K945105

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945105 Date14 May 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
ETB
Device Class
Class II
Regulation
21 CFR Part 874.3450
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

This device is a prosthesis, partial ossicular replacement, as defined in the device type and openfda fields. It is constructed of poly/platinum wire and functions as a piston for middle ear reconstruction.

It is supplied as a sterile, single-use implant intended for use in otologic surgery. The device received FDA 510(k) clearance (K945105) and is classified as a Class II medical device under regulation number 874.3450, with product code ETB and medical specialty in Ear, Nose, Throat.

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Questions

AI-generated answers, 23 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 is the POLY/PLATINUM WIRE PISTON used for?

    It is a prosthesis designed as a partial ossicular replacement piston for middle ear reconstruction in otologic surgery, functioning to restore sound conduction by replacing damaged ossicles.

  • How is the POLY/PLATINUM WIRE PISTON supplied and is it reusable?

    The device is supplied sterile and intended for single-use only; it must not be reused, reprocessed, or resterilized due to risk of contamination, material degradation, and compromised performance.

  • What materials is the POLY/PLATINUM WIRE PISTON made from and what regulatory pathway was used?

    It is constructed of poly/platinum wire and received FDA 510(k) clearance via traditional submission (K945105), demonstrating substantial equivalence to a legally marketed predicate device.