ENFit enteral syringe— 510(k) K161979

Clearance details

Applicant

Jiangyin Caina Technology Co., Ltd.

Product code

Code PNR

Device class

Class 2

Regulation

21 CFR 876.5980

Advisory panel

Gastroenterology, Urology

Date received

2016-07-18

Decision date

2017-03-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jiangyin, CN

• K252483 — Enteral Syringe (20ml, 60ml)2026-07-01
• K253268 — Profoject Enteral/Oral Feeding Syringe +3 more2026-04-08
• 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

• K152323 — Disposable Infusion Needle, Safelock Disposable Infusion Needle2015-12-14
• K151991 — Safelock Disposable Blood Collection Set, Disposable Blood Collection Set2015-12-11
• K151949 — Disposable Insulin Syringe2015-10-02
• K150758 — Safety Disposable Insulin Syringe2015-06-18
• K141359 — HARD PACK SYRINGE2014-07-25

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 →