VARICES NEEDLE
FDA 510(k) clearance K031238 · decided 2004-10-04
Clearance details
- K-number
- K031238
- Device name
- VARICES NEEDLE
- Applicant
- Scandimed. A.S.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-18
- Decision date
- 2004-10-04
- Days to decision
- 535 days
- Clearance type
- Traditional
- Product code
- FBK
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Collegeville, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.