Urogram Cystometrogram
FDA 510(k) K936041 · Myo/Kinetic Systems, Inc.
510(k) numberK936041
Submission
- Device name
- Urogram Cystometrogram
- Applicant
- Myo/Kinetic Systems, Inc.
Menomonee Falls, WI, US - Received
- December 20, 1993
- Decision date
- April 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code FEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212830 | CT3000ProFEN · Traditional | Srs Medical | 12/21/2021SE |
| K082701 | Uronirs, Model 2000FEN · Traditional | Urodynamix Technologies, Ltd. | 12/18/2008SE |
| K073552 | Laborie Urodynamic System with Tetra AccessoryFEN · Traditional | Laborie Medical Technologies, Corp. | 03/05/2008SE |
| 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 |
|---|---|---|
| K945937 | TE-800 Pelvic Floor ExerciserHIR · Traditional | 07/14/1995SE |
| K945292 | TS-700P Control XP Electrical StimulatorKPI · Traditional | 04/12/1995SE |
| K944972 | Uro-Gram Cystomrtrogram with UroflowmetryEXY · Traditional | 03/08/1995SE |
| K932611 | Neuromuscular StimulatorGZJ · Traditional | 01/31/1994SE |
| K932764 | Therapeutic Stimulator 300(TS-300) & 300P(TS-300P)IPF · Traditional | 10/01/1993SE |
| K932399 | Therapeutic Stim 200 (TS-200)/200P (TS-200P)IPF · Traditional | 08/11/1993SE |
| K914904 | Therapeutic Stimulator 2100 (TS-2100)IPF · Traditional | 04/28/1992SE |
Questions and answers
When was Urogram Cystometrogram cleared by the FDA?
Urogram Cystometrogram (K936041) received a 510(k) decision of Substantially Equivalent on April 18, 1994, 119 days after the submission was received.
What is the product code of K936041?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.