Data / Medical devices / United States / Black Diamond Video, Inc.
Black Diamond Video, Inc.: FDA-registered device maker in Richmond, CA, United States, 4 510(k) clearances
Black Diamond Video, Inc. is registered with the FDA (registration 3008776287) in Richmond, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 25, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008776287
- Address
- 503 Canal Blvd, Richmond, CA, United States, 94804
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- October 9, 2020
- Registered through
- 2027
- Brand names listed
- 55" Vividimage W HD Wall Display (RM-RR), 58" Display Monitor (8MP) (RM-RR), A-Series HD Camera (MG-MF), Free 5 Camera System (RM-CFE), G-Series HD Camera in Case (MG-MF), Harmony iQ 2400-SLC (RM-CFE), Harmony iQ 2400-SLC (RM-CFE), Harmony iQ 2800-SLC (RM-CFE) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Surgical And Accessories | KQM | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2023 | K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 | FGB | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 17, 2023 | K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 | FGB | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| November 23, 2021 | K211347 | Uretero1 Ureteroscope System | FGB | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 7, 2014 | K133413 | IDSS SLC | FTA | Substantially Equivalent | Black Diamond Video | accessdata.fda.gov |
Compare with other makers
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Camera, Surgical And Accessories
- All makers of Light, Surgical, Accessories
Updated July 25, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.