ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
FDA 510(k) clearance K030064 · decided 2003-01-22
Clearance details
- K-number
- K030064
- Device name
- ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
- Applicant
- Sonosite,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-07
- Decision date
- 2003-01-22
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite recall (Z-0407-06) | Sonosite, Inc. | 2006-01-19 |