Statnet
FDA 510(k) K970525 · Gorca Systems, Inc.
510(k) numberK970525
Submission
- Device name
- Statnet
- Applicant
- Gorca Systems, Inc.
Moorestown, NJ, US - Received
- February 11, 1997
- Decision date
- April 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | Stryker Endoscopy | 05/28/2026SE |
| K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging PlatformIZI · Traditional | Surgimage Corporation | 05/13/2026SE |
| K243645 | IC-Flow Imaging System 2.0IZI · Traditional | Diagnostic Green GmbH | 09/22/2025SE |
| K243077 | Affirm 800IZI · Traditional | Digital Surgery Systems, Inc. (D.B.A True… | 06/27/2025SE |
| K231986 | Modus IRIZI · Traditional | Synaptive Medical, Inc. | 03/25/2024SE |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)IZI · Traditional | Surgvision GmbH | 03/20/2024SE |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZI · Traditional | Carl Zeiss Meditec, Inc. | 06/20/2023SE |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | Novadaq Technologies Ulc (A Part of Stryker) | 06/05/2023SE |
| K222240 | Explorer Air® IIIZI · Traditional | Surgvision GmbH | 02/28/2023SE |
| K214097 | Explorer Air IIIZI · Traditional | Surgvision GmbH | 02/25/2022SE |
Questions and answers
When was Statnet cleared by the FDA?
Statnet (K970525) received a 510(k) decision of Substantially Equivalent on April 16, 1997, 64 days after the submission was received.
What is the product code of K970525?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.