Bioglass Ossicular Reconstruction Prosth
FDA 510(k) K843461 · American Biomaterials Corp.
510(k) numberK843461
Submission
- Device name
- Bioglass Ossicular Reconstruction Prosth
- Applicant
- American Biomaterials Corp.
Princeton, NJ, US - Received
- September 5, 1984
- Decision date
- January 9, 1985
- 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
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| 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 |
|---|---|---|
| K922455 | Evert-O-Cath CatheterDQO · Traditional | 07/07/1994SE |
| K924725 | American Biomed, Inc. Microsurgical InstrumentsMDM · Traditional | 02/05/1993SE |
| K915824 | Hole PunchFOZ · Traditional | 01/29/1993SE |
| K880371 | Bioglass Dental Endosseous Ridge MaintainerLYC · Traditional | 11/18/1988SE |
| K863796 | Creative Care Systems' IV Start KitLRS · Traditional | 11/28/1986SE |
Questions and answers
When was Bioglass Ossicular Reconstruction Prosth cleared by the FDA?
Bioglass Ossicular Reconstruction Prosth (K843461) received a 510(k) decision of Substantially Equivalent on January 9, 1985, 126 days after the submission was received.
What is the product code of K843461?
The FDA product code is ETA – Replacement, Ossicular Prosthesis, Total, a Class II (moderate risk) device regulated under 21 CFR 874.3495.