Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector— 510(k) K222155

Name: FDA 510(k) clearance K222155
Creator: U.S. Food and Drug Administration
Published: 2022-09-16

Substantially Equivalent

Jiangsu Caina Medical Co.,Ltd

FDA 510(k) clearance K222155 for Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector, Substantially Equivalent on 2022-09-16. Applicant: Jiangsu Caina Medical Co.,Ltd. Device class: 2.

Clearance details

Applicant: Jiangsu Caina Medical Co.,Ltd
Product code: Code PNR
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2022-07-20
Decision date: 2022-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiangyin, CN

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

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K232781 — Safety Sliding Blood Collection Set2024-03-07
K233190 — ENFit Adaptor2024-01-18
K230635 — Pen Needle2023-06-02
K222834 — Safety Push Button Blood Collection Set2023-01-05
K221406 — Vented Vial Transfer Pin2022-10-28

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.