Bartels Bucket Handle 427-375

• FDA 510(k) K060518 decided 28 Jun 2006 Active
• FDA GUDID UDI-DI 00844505001564 listed 18 Feb 2016 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. 18 Feb 2016 Listed FDA GUDID 00844505001564
3. 3 Apr 2026 Recall initiated FDA recalls Z-2308-2026

Trade name

Bartels Bucket Handle

Generic name

Ossicular prosthesis, partial

Model / reference

427-375

Primary DI / UDI-DI

00844505001564

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 Conditional

Category: Ossicular prosthesis, partial

Other devices filed under FDA product code ETB (PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT).

• INCUS PROSTHESIS by Richards Medical Co., Inc.
• RICHARDS PORP by Smith & Nephew Richards, Inc.
• CAP PORP, CAP TORP by Gyrus Ent LLC
• TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 by Heinz Kurz
• Exmoor Teflon Loop Replacement Prosthesis by Exmoor Plastics, Ltd.
• Drumto Stapes Prosthesis by Humboldt Products
• CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 by Heinz Kurz GmbH Medizintechnik
• Poly/Platinum Wire Piston by Micromed Development Corp.
• Schuring Ossicle Cup & Columella Prosth. by Richard'S Medical Equip., Inc.
• Smith & Nephew Pistons 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. →