Integrated Visualization System
FDA 510(k) K925108 · Neuro Navigational Corp.
510(k) numberK925108
Submission
- Device name
- Integrated Visualization System
- Applicant
- Neuro Navigational Corp.
Costa Mesa, CA, US - Received
- October 9, 1992
- Decision date
- January 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FWF – Camera, Television, Endoscopic, Without Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Specialty
- General, Plastic Surgery
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| K982754 | EC-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (NTSC)FWF · Traditional | A.Stein - Regulatory Affairs Consulting | 01/08/1999SE |
| K982965 | Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesFWF · Traditional | Richard Wolf Medical Instruments Corp. | 11/23/1998SE |
| K982397 | Ves 3001-M Complete Video Endoscopic SystemFWF · Traditional | Angiolaz, Inc. | 09/10/1998SE |
| K982409 | Ves 1501-MFWF · Traditional | Angiolaz, Inc. | 08/21/1998SE |
| K981819 | Angiolaz VES-1CAMFWF · Traditional | Angiolaz, Inc. | 08/04/1998SE |
| K944707 | Isolated Camera HeadFWF · Traditional | Envision Medical Corp. | 10/07/1994SE |
| K930297 | Fujinon Video Laparoscope, ModifiedFWF · Traditional | Fujinon, Inc. | 03/29/1994SE |
| K934682 | Surgical Video Camera and AccessoriesFWF · Traditional | Medical Dynamics, Inc. | 02/15/1994SE |
More from Medical Dynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K965078 | 2.1MM Semi-Rigid Neuroview SCISSORS/2.0OMM Semi-Rigid Neuroview Grasping ForcepsGWG · Traditional | 03/06/1997SE |
| K961406 | Neuroview ScissorsGWG · Traditional | 06/13/1996SE |
| K961300 | Aspiration/Irrigation CatheterGWG · Traditional | 06/07/1996SE |
| K961173 | 1.2MM Reusable Neuroview EndoscopeGWG · Traditional | 06/07/1996SE |
| K960792 | Disposable Neuroview Introducer SheathGWG · Traditional | 04/11/1996SE |
| K954938 | Disposable Neuroview Operating SheathGWG · Traditional | 03/07/1996SE |
| K955351 | Neuroview Coaxial Bipolar ElectrodeGWG · Traditional | 02/29/1996SE |
| K954899 | Rigid Neuroview EndoscopeGWG · Traditional | 12/19/1995SE |
| K955467 | Neuroview Coaxial Bipolar ElectrodeGEI · Traditional | 12/18/1995SE |
| K955037 | Rigid Neuroview EndoscopeHRX · Traditional | 12/04/1995SN |
Questions and answers
When was Integrated Visualization System cleared by the FDA?
Integrated Visualization System (K925108) received a 510(k) decision of Substantially Equivalent on January 29, 1993, 112 days after the submission was received.
What is the product code of K925108?
The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.