Lumax (Modification)
FDA 510(k) K954093 · Medamicus, Inc.
510(k) numberK954093
Submission
- Device name
- Lumax (Modification)
- Applicant
- Medamicus, Inc.
Minneapolis, MN, US - Received
- August 9, 1995
- Decision date
- January 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEN – Device, Cystometric, Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
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| K001386 | Accuset Sensor, Model 2000FEN · Traditional | Pelvicare, Inc. | 07/17/2000SE |
| K992715 | Neuro Urodynamic Suite, Model 9032E0101FEN · Traditional | Medtronic Functional Diagnostics A/S | 02/28/2000SE |
| K983325 | In-Probe II Urodynamic SystemFEN · Traditional | Influence, Inc. | 11/24/1998SE |
| K970595 | Circon Endotek OM-4 H2O Cystometry PumpFEN · Traditional | Circon Video | 10/24/1997SE |
| K971911 | Lumax Cystometry Administration Tube SetFEN · Traditional | Medamicus, Inc. | 06/03/1997SE |
| K964522 | Ellipse 4FEN · Traditional | Andromeda Medizinische Systeme GmbH | 03/21/1997SE |
| K960503 | Dantec DuetFEN · Traditional | Dantec Medical, Inc. | 09/16/1996SE |
More from Dantec Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K040150 | Modification to Medamicus Flowguard Peelable IntroducerDYB · Special | 02/18/2004SE |
| K030905 | Medamicus Flowguard Peelable IntroducerDYB · Special | 04/09/2003SE |
| K022689 | Modification to Medamicus Axia RSNDYB · Special | 08/23/2002SE |
| K021004 | Valved Peelable IntroducerDYB · Traditional | 06/06/2002SE |
| K020563 | Medamicus Axia RSNDYB · Traditional | 05/21/2002SE |
| K013120 | Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18GZB · Traditional | 01/24/2002SE |
| K011085 | Guidewire Introducer Safety NeedleDYB · Traditional | 07/09/2001SE |
| K000824 | Percutaneous Introducer, Model 10383-XXXDYB · Special | 04/13/2000SE |
| K994097 | Medamicus Epidural IntroducerGZB · Traditional | 03/01/2000SE |
| K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetDYB · Traditional | 06/28/1999SE |
Questions and answers
When was Lumax (Modification) cleared by the FDA?
Lumax (Modification) (K954093) received a 510(k) decision of Substantially Equivalent on January 11, 1996, 155 days after the submission was received.
What is the product code of K954093?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.