Godat Uterine Manipulator Injector
FDA 510(k) K935023 · Ideas For Medicine, Inc.
510(k) numberK935023
Submission
- Device name
- Godat Uterine Manipulator Injector
- Applicant
- Ideas For Medicine, Inc.
Clearwater, FL, US - Received
- October 20, 1993
- Decision date
- January 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Decision |
|---|---|---|
| K961883 | Versa-Cath Arterial CatheterDXE · Traditional | 01/13/1997SE |
| K962751 | Ideas' Dual PortLJT · Traditional | 09/30/1996SE |
| K961716 | Vaso-Safe Arterial Embolectomy CatheteDXE · Traditional | 09/19/1996SE |
| K960715 | Pruitt-Inahara Carotid Shunt 400-40-8F/INAHARA-PRUITT Carotid Shunt 500-50-8FMJN · Traditional | 09/09/1996SE |
| K960422 | Pruitt Safety Occlusion CatheterMJN · Traditional | 08/07/1996SE |
| K954713 | Dural-Lumen Intra Vascular Balloon Catheter (Modification)FGE · Traditional | 07/24/1996SE |
| K935964 | Ideas OccluderDXC · Traditional | 01/04/1995SE |
| K880231 | Modified Pruitt Irrigation & Occlusion CatheterDQT · Traditional | 05/25/1988SE |
| K872090 | The Robicsek - Pruitt Aortic Balloon Occlusion KitDQT · Traditional | 10/30/1987SE |
| K872485 | Change of Catheter Body Material (Radio-Opaque Ny)DXE · Traditional | 08/12/1987SE |
Questions and answers
When was Godat Uterine Manipulator Injector cleared by the FDA?
Godat Uterine Manipulator Injector (K935023) received a 510(k) decision of Substantially Equivalent on January 4, 1995, 441 days after the submission was received.
What is the product code of K935023?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.