DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories— 510(k) K170900

Substantially Equivalent

Intervene Group, Ltd.

FDA 510(k) clearance K170900 for DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories, Substantially Equivalent on 2017-11-09. Applicant: Intervene Group, Ltd..

Clearance details

Applicant: Intervene Group, Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2017-03-27
Decision date: 2017-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uxbridge, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.