Clearance Summary
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 received FDA 510(k) clearance under submission number K170371, sponsored by Intervene Group Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2017-10-20.
- Submission: K170371
- Applicant / Sponsor: Intervene Group Limited
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2017-10-20
Classification & Regulation
This clearance is catalogued under FDA product code PNR and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.