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Shea Cupped Torp With Hydroxylapatite Flange

by Richards Medical Co., Inc. 510(k)

Active United States

510(k) K864444

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864444 Date6 Feb 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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, 22 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 Shea Cupped Torp With Hydroxylapatite Flange is an ossicular prosthesis, total, used in ear, nose, and throat applications. It is a replacement prosthesis. The device features a hydroxylapatite flange.

The device is supplied as a single unit and is intended for use in a medical setting. It has been assigned a product code of ETA and is regulated under 874.3495. The device has been cleared by the FDA under the traditional clearance type with a decision code of SESE.

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