INJECTION NEEDLE PROBE/DEVICE-TUNIS
FDA 510(k) clearance K983765 · decided 1998-12-11
Clearance details
- K-number
- K983765
- Device name
- INJECTION NEEDLE PROBE/DEVICE-TUNIS
- Applicant
- Ximed/Prosure/Injectx
- Decision
- Substantially Equivalent
- Date received
- 1998-10-26
- Decision date
- 1998-12-11
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- FBK
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.