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— 510(k) K170371

Substantially Equivalent

Intervene Group Limited

FDA 510(k) clearance K170371 for 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, Substantially Equivalent on 2017-10-20. Applicant: Intervene Group Limited.

Clearance details

Applicant: Intervene Group Limited
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2017-02-06
Decision date: 2017-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uxbridge, GB

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Adverse events under product code PNR

product code PNR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.