SWIFT-LOCK ANCHOR, MODEL 1192
FDA 510(k) clearance K092371 · decided 2009-12-23
Clearance details
- K-number
- K092371
- Device name
- SWIFT-LOCK ANCHOR, MODEL 1192
- Applicant
- Advanced Neuromodulation Systems
- Decision
- Substantially Equivalent
- Date received
- 2009-08-05
- Decision date
- 2009-12-23
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- GZB
- Device class
- 2
- Regulation number
- 882.5880
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Plano, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medic recall (Z-1425-2010) | Advanced Neuromodulation Systems, Inc | 2010-04-21 |