FDA device listing
Pinpoint Light Cable,SPY-PHI Handheld Imager,SPY-PHI System,SPY Portable Handheld Imaging (SPY-PHI) System,Video…
FDA device listing 1602754692 · STRYKER CORP.
Key facts
| Proprietary names | Pinpoint Light Cable,SPY-PHI Handheld Imager,SPY-PHI System,SPY Portable Handheld Imaging (SPY-PHI) System,Video Processor / Illuminator VPI |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K200737 |
| Product codes | GCJ, IZI, OWN |
| Device names | GCJ - Laparoscope, General & Plastic Surgery, IZI - System, X-Ray, Angiographic, OWN - Confocal Optical Imaging |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 892.1600 |
| Review panels | Gastroenterology & Urology, Radiology |
| Registered establishments | Novadaq Technologies ULC, STRYKER ENDOSCOPY |
| Establishment registrations | 2936485, 3012345110 |
| FEI numbers | 2936485, 3012345110 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database