EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
FDA 510(k) clearance K010179 · decided 2001-02-09
Clearance details
- K-number
- K010179
- Device name
- EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
- Applicant
- Ebi, L.P.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-19
- Decision date
- 2001-02-09
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EBI VueCath Endoscopic Spinal System recall (Z-1006-03) | EBI, L.P. | 2003-07-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SCOLITRON(TM) STIMULATOR (P820008/S005) | Ebi, L.P. | 1987-04-02 |
| SCOLITRON(TM) STIMULATOR (P820008/S004) | Ebi, L.P. | 1987-01-07 |
| SCOLITRON(TM) STIMULATOR (P820008/S003) | Ebi, L.P. | 1986-09-12 |
| SCOLITRON(TM) STIMULATOR (P820008/S002) | Ebi, L.P. | 1986-01-17 |
| SCOLITRON(TM) STIMULATOR (P820008/S001) | Ebi, L.P. | 1983-06-14 |
| SCOLITRON(TM) STIMULATOR (P820008) | Ebi, L.P. | 1983-01-06 |