DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
FDA 510(k) clearance K032473 · decided 2003-11-07
Clearance details
- K-number
- K032473
- Device name
- DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 2003-08-12
- Decision date
- 2003-11-07
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable di recall (Z-0127-2014) | Stryker Instruments Div. of Stryker Corporation | 2013-11-01 |
| Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, recall (Z-1829-2011) | Stryker Instruments Division of Stryker Corporation | 2011-03-28 |
| Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, recall (Z-1830-2011) | Stryker Instruments Division of Stryker Corporation | 2011-03-28 |