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

Name: FDA 510(k) clearance K170371
Creator: U.S. Food and Drug Administration
Published: 2017-10-20

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. Device class: 2.

Clearance details

Applicant: Intervene Group Limited
Product code: Code PNR
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2017-02-06
Decision date: 2017-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uxbridge, GB

Download summary PDF View on FDA.gov ↗

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K251585 — Profoject Enteral Feeding Syringe2025-07-18
K243652 — Monoject Enteral Syringe with ENFit Connector (6 models)2024-12-19
K231300 — Nutricair Enteral Syringe with ENFit2023-10-06

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.