Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM
FDA 510(k) K042503 · Heinz Kurz GmbH Medizintechnik
510(k) numberK042503
Submission
- Device name
- Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM
- Applicant
- Heinz Kurz GmbH Medizintechnik
Amsterdam, Nh, NL - Received
- September 15, 2004
- Decision date
- October 1, 2004
- 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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| 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 |
| 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 |
| K001902 | Bojrab Universal Long Imlant, Model TBDETA · Traditional | Gyrus Ent LLC | 07/10/2000SE |
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| K112616 | Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisETB · Traditional | 02/08/2013SE |
| K071150 | Trocar Ventilation Tube/With Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015…ETD · Traditional | 12/12/2007SE |
| K033796 | Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BSKHJ · Traditional | 01/30/2004SE |
| K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861ETB · Special | 05/21/2002SE |
| K013573 | Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257ETB · Special | 11/09/2001SE |
| K011115 | Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007…MML · Special | 05/02/2001SE |
| K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170ETB · Traditional | 08/09/2000SE |
| K001123 | Kurz Upper Eyelid Implant Sizers, Model 8000 111MML · Traditional | 04/21/2000SE |
| K000127 | Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10MML · Traditional | 04/12/2000SE |
Questions and answers
When was Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM cleared by the FDA?
Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM (K042503) received a 510(k) decision of Substantially Equivalent on October 1, 2004, 16 days after the submission was received.
What is the product code of K042503?
The FDA product code is ETA – Replacement, Ossicular Prosthesis, Total, a Class II (moderate risk) device regulated under 21 CFR 874.3495.