3-CHIP VIDEO CAMERA
FDA 510(k) clearance K983566 · decided 1999-01-11
Clearance details
- K-number
- K983566
- Device name
- 3-CHIP VIDEO CAMERA
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1998-10-13
- Decision date
- 1999-01-11
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for us recall (Z-1558-2008) | Stryker Endoscopy | 2008-08-24 |