SE5 ARTHROSCOPY SYTEM
FDA 510(k) clearance K941333 · decided 1994-11-10
Clearance details
- K-number
- K941333
- Device name
- SE5 ARTHROSCOPY SYTEM
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1994-03-18
- Decision date
- 1994-11-10
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryke recall (Z-1872-2014) | Stryker Endoscopy | 2014-06-25 |