COOK WIRE GUIDES
FDA 510(k) clearance K082536 · decided 2008-10-27
Clearance details
- K-number
- K082536
- Device name
- COOK WIRE GUIDES
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-02
- Decision date
- 2008-10-27
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- OCY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC recall (Z-1837-2022) | Cook Incorporated | 2022-09-28 |