Microtek Total Ossicular Prothesis
FDA 510(k) K895815 · Microbio-Medics, Inc.
510(k) numberK895815
Submission
- Device name
- Microtek Total Ossicular Prothesis
- 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
- ETA – Replacement, Ossicular Prosthesis, Total
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3495
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code ETA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691)…ETA · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total…ETA · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K091187 | Grace Dynamic TorpETA · Traditional | Grace Medical, Inc. | 09/14/2009SE |
| K083780 | Superelelastic Nitinol Piston, Superelastic Nitinol Trimmable Piston, Model…ETA · Traditional | Audio Technologies S.R.L. | 03/23/2009SE |
| K043375 | Fisch Titanium Middle Ear ProsthesesETA · Traditional | Karl Storz Endoscopy | 01/24/2005SE |
| K042503 | Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMETA · Traditional | Heinz Kurz GmbH Medizintechnik | 10/01/2004SE |
| K030492 | Titanium Ossicular Replacment SystemETA · Traditional | Invotec International, Inc. | 03/03/2003SE |
| K002378 | Modular Porp and Torp Model TBDETA · Traditional | Gyrus Ent LLC | 08/29/2000SE |
| K001406 | Ha/Gold Total and Partial, Regular and Offset, Ossicular Replacement ProsthesesETA · Traditional | Mednet Locator, Inc. | 08/08/2000SE |
| K001404 | Gold Total and Partial, Regular and Offset, Ossicular Replacement Prostheses, Gold Total…ETA · Traditional | Mednet Locator, Inc. | 08/08/2000SE |
More from Mednet Locator, 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 |
| K895814 | Microtek Piston & Wire ProsthesesETB · 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 Total Ossicular Prothesis cleared by the FDA?
Microtek Total Ossicular Prothesis (K895815) 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 K895815?
The FDA product code is ETA – Replacement, Ossicular Prosthesis, Total, a Class II (moderate risk) device regulated under 21 CFR 874.3495.