Microtek Piston & Wire Prostheses
FDA 510(k) K895814 · Microbio-Medics, Inc.
510(k) numberK895814
Submission
- Device name
- Microtek Piston & Wire Prostheses
- Applicant
- Microbio-Medics, Inc.
Columbus, MS, US - Received
- September 29, 1989
- Decision date
- December 26, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K923353 | Ventilation Tubes W/ Hydrogel CoatingETD · Traditional | 05/18/1993SE |
| K922572 | 321Q Minimum Energy Tinnitus SuppressorKLW · Traditional | 11/02/1992SE |
| K913276 | Microtek Medical's Sound StiksEWO · Traditional | 10/21/1991SE |
| K904239 | Soft Hydroxylapatite Ossicular Malleable ProsthesETA · Traditional | 06/21/1991SE |
| K910167 | Microtek-Heritages Silicone Bulb Evacuation SystemGCY · Traditional | 04/15/1991SE |
| K900726 | Microtek Medical's Blood Collection KitJKA · Traditional | 05/04/1990SE |
| K901154 | Microtek's Surgical Lamp Handle & CoverFTA · Traditional | 03/20/1990SE |
| K895815 | Microtek Total Ossicular ProthesisETA · Traditional | 12/26/1989SE |
| K895502 | Microtek Reuter-Style Bi-Valve Intranasal SplintEPP · Traditional | 12/08/1989SE |
| K885201 | Ossicular Prostheses 4 Partial, 4 Total, 2 ConvertETA · Traditional | 04/19/1989SE |
Questions and answers
When was Microtek Piston & Wire Prostheses cleared by the FDA?
Microtek Piston & Wire Prostheses (K895814) received a 510(k) decision of Substantially Equivalent on December 26, 1989, 88 days after the submission was received.
What is the product code of K895814?
The FDA product code is ETB – Prosthesis, Partial Ossicular Replacement, a Class II (moderate risk) device regulated under 21 CFR 874.3450.