STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
FDA 510(k) clearance K132785 · decided 2013-12-16
Clearance details
- K-number
- K132785
- Device name
- STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2013-09-06
- Decision date
- 2013-12-16
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition recall (Z-0569-2015) | Stryker Endoscopy | 2014-12-12 |
| 1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount recall (Z-0570-2015) | Stryker Endoscopy | 2014-12-12 |
| 1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated C recall (Z-0571-2015) | Stryker Endoscopy | 2014-12-12 |