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Modular Porp And Torp Model Tbd

by Gyrus Ent LLC

510(k) K002378

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 NumberK002378 Date29 Aug 2000ClearedStatusActive

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  • Withdrawn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
ETA
Device Class
Class II
Regulation
21 CFR Part 874.3495
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.

The Modular Porp and Torp Model Tbd is a total ossicular replacement prosthesis. It is designed to be implanted for the functional reconstruction of the ossicular chain to facilitate the conduction of sound waves from the tympanic membrane to the inner ear.

This device is regulated under 21 CFR 874.3495 and has received FDA 510(k) clearance under number K002378. It is classified as a Class 2 medical device within the Ear, Nose, and Throat specialty.

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