AUTO SUTURE KERRISON SPINAL RONGEUR
FDA 510(k) clearance K943116 · decided 1994-07-27
Clearance details
- K-number
- K943116
- Device name
- AUTO SUTURE KERRISON SPINAL RONGEUR
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1994-06-27
- Decision date
- 1994-07-27
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- HAE
- Device class
- 2
- Regulation number
- 882.4840
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expandin recall (Z-2832-2011) | Boston Scientific Corporation | 2011-07-15 |