Ossicular Prosthesis: 8 Partial, 3 Total

by Porex Technologies Corp. of Georgia 510(k)

Active United States

510(k) K884884

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK884884	Date16 Jun 1989Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number: K884884
FDA Product Code: ETA

Device Class: Class II
Regulation: 21 CFR Part 874.3495
Advisory Committee: Ear, Nose, Throat
FDA Decision: SESE Substantially Equivalent

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Class II