OM-4 (Tenative) Urodynamic Measruement System
FDA 510(k) K944391 · Surgitek
510(k) numberK944391
Submission
- Device name
- OM-4 (Tenative) Urodynamic Measruement System
- Applicant
- Surgitek
Racine, WI, US - Received
- September 9, 1994
- Decision date
- February 7, 1995
- 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
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| 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.
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|---|---|---|
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| K943491 | Right Angle Urologic Laser FiberGEX · Traditional | 08/05/1994SE |
| K941952 | Surgitek InfuserFAD · Traditional | 05/24/1994SE |
| K933261 | Grasping ForcepsFGO · Traditional | 01/11/1994SE |
| K933260 | Helical Stone/Flatwire Stone BasketsFFL · Traditional | 01/11/1994SE |
| K930733 | Ureteral StentFAD · Traditional | 07/23/1993SE |
| K930483 | Ureteral CatheterEYB · Traditional | 07/16/1993SESK |
| K926344 | Hydrophilic Coated GuidewireKNY · Traditional | 03/05/1993SE |
| K920451 | Endotek Ultra SystemFAP · Traditional | 09/17/1992SE |
| K922542 | Grasping ForcepsFGO · Traditional | 08/19/1992SE |
Questions and answers
When was OM-4 (Tenative) Urodynamic Measruement System cleared by the FDA?
OM-4 (Tenative) Urodynamic Measruement System (K944391) received a 510(k) decision of Substantially Equivalent on February 7, 1995, 151 days after the submission was received.
What is the product code of K944391?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.