Poly-Wire Piston
FDA 510(k) K945107 · Micromed Development Corp.
510(k) numberK945107
Submission
- Device name
- Poly-Wire Piston
- Applicant
- Micromed Development Corp.
Clearwater, FL, US - Received
- October 18, 1994
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ETB – Prosthesis, Partial Ossicular Replacement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3450
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code ETB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)…ETB · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm)…ETB · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and…ETB · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…ETB · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K130512 | Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisETB · Traditional | Heinz Kurz GmbH Medizintechnik | 12/02/2013SE |
| K112616 | Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisETB · Traditional | Heinz Kurz GmbH Medizintechnik | 02/08/2013SE |
| K080070 | K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 04/17/2008SE |
| K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…ETB · Traditional | Grace Medical, Inc. | 12/06/2006SE |
| K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 08/18/2006SE |
| K060518 | Partial Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 06/28/2006SE |
More from Grace Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945105 | Poly/Platinum Wire PistonETB · Traditional | 05/14/1996SE |
| K945831 | Disposable Joint Aspiration/Injection Diagnostic KitLRO · Traditional | 01/20/1995SE |
| K945242 | Nerve Monitor Electrodes/Stimulator ProbesETN · Traditional | 12/27/1994SE |
| K945438 | Edi-Bur Microdrill SystemsERL · Traditional | 11/22/1994SE |
| K945108 | Poly PistonETB · Traditional | 11/22/1994SE |
| K945106 | Micromed Total Regular and Partial OffsetETA · Traditional | 11/22/1994SE |
| K945104 | Micromed Partial Regular and Partial OffsetETB · Traditional | 11/22/1994SE |
| K943848 | Collar Button Venturi Vent TubeETD · Traditional | 09/16/1994SE |
| K943849 | Gromment Style Venturi TubeETD · Traditional | 09/02/1994SE |
| K943847 | Bobbin Style Venturi Vent TubeETD · Traditional | 09/02/1994SE |
Questions and answers
When was Poly-Wire Piston cleared by the FDA?
Poly-Wire Piston (K945107) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 35 days after the submission was received.
What is the product code of K945107?
The FDA product code is ETB – Prosthesis, Partial Ossicular Replacement, a Class II (moderate risk) device regulated under 21 CFR 874.3450.