MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
FDA 510(k) clearance K020985 · decided 2002-06-25
Clearance details
- K-number
- K020985
- Device name
- MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
- Applicant
- Tfx Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-27
- Decision date
- 2002-06-25
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jaffrey, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.