Fluoroplastic Piston 400-600

• FDA 510(k) K060518 decided 28 Jun 2006 Active
• FDA GUDID UDI-DI 00844505000482 listed 21 Nov 2017 Listed

• • Ongoing Z-2308-2026 FDA Class II ·initiated 3 Apr 2026

  Due to incorrect functional length on device labeling.

1. 28 Jun 2006 Cleared FDA 510(k) K060518
2. 21 Nov 2017 Listed FDA GUDID 00844505000482
3. 3 Apr 2026 Recall initiated FDA recalls Z-2308-2026

Trade name

Fluoroplastic Piston

Generic name

Ossicular prosthesis, partial

Model / reference

400-600

Primary DI / UDI-DI

00844505000482

510(k) Number

K060518 ↗

FDA product code

ETB

GMDN term

Ossicular prosthesis, partial

Device class

Class II

Regulation number

874.3450

GUDID distribution status

In Commercial Distribution

MRI safety

MR Safe

Category: Ossicular prosthesis, partial

Other devices filed under FDA product code ETB (Prosthesis, Partial Ossicular Replacement).

• BUCKET PROSTHESIS PORP by Treace Medical, Inc.
• TEF/PLATINUM PISTON by River Medical, Inc.
• PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) by Mednet Locator, Inc.
• Audioprosthesis SPL 03.00.400 by AUDIO TECHNOLOGIES SRL
• WEHRS INCUS AND INCUS-STAPES PROSTHESES by Smith & Nephew Richards, Inc.
• CAUSSE MODIFIED TEFLON PISTON, OTOLOGY by Richard'S Medical Equip., Inc.
• CAUSSE SPONGE BOAT by Treace Medical, Inc.
• APACERAM OSSICULAR PROSTHESIS by Asahi Optical Co. C/O Rosati Associates, P.C.
• SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS by Gyrus Ent LLC
• RICHARDS TOTAL/PARTIAL PROSTHESIS by Gyrus Ent LLC

• Titanium/Fluoroplastic Piston 409-600 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-525 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-550 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-575 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

See all devices from Grace Medical, Inc. →