Bojrab Universal Long Imlant, Model TBD
FDA 510(k) K001902 · Gyrus Ent LLC
510(k) numberK001902
Submission
- Device name
- Bojrab Universal Long Imlant, Model TBD
- Applicant
- Gyrus Ent LLC
Bartlett, TN, US - Received
- June 22, 2000
- Decision date
- July 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total…ETA · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
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| 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 |
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| K021595 | Gyrus ENT Nerve StimulatorETN · Traditional | 10/24/2002SE |
| K021777 | Gyrus ENT Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…GEI · Traditional | 08/26/2002SE |
| K020778 | Gyrus ENT Somnoplasty Tissue Coagulating Electrode, Model 2420GEI · Traditional | 05/28/2002SE |
| K020067 | Gyrus ENT Somnoplasty GeneratorGEI · Traditional | 04/04/2002SE |
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Questions and answers
When was Bojrab Universal Long Imlant, Model TBD cleared by the FDA?
Bojrab Universal Long Imlant, Model TBD (K001902) received a 510(k) decision of Substantially Equivalent on July 10, 2000, 18 days after the submission was received.
What is the product code of K001902?
The FDA product code is ETA – Replacement, Ossicular Prosthesis, Total, a Class II (moderate risk) device regulated under 21 CFR 874.3495.