DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
FDA 510(k) clearance K170371 · decided 2017-10-20
Clearance details
- K-number
- K170371
- Device name
- DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
- Applicant
- Intervene Group Limited
- Decision
- Substantially Equivalent
- Date received
- 2017-02-06
- Decision date
- 2017-10-20
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- PNR
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Uxbridge, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.