STRYKER SCOPE WARMER
FDA 510(k) clearance K053311 · decided 2006-01-27
Clearance details
- K-number
- K053311
- Device name
- STRYKER SCOPE WARMER
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2005-11-28
- Decision date
- 2006-01-27
- Days to decision
- 60 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 |
|---|---|---|
| Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC recall (Z-2622-2010) | Stryker Endoscopy | 2010-09-29 |