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510(k) K161979

ENFit enteral syringe by Jiangyin Caina Technology Co., Ltd. — Product Code PNR

K161979 is an FDA 510(k) premarket notification submitted by Jiangyin Caina Technology Co., Ltd. for the device "ENFit enteral syringe". The FDA issued a decision of Substantially Equivalent on Mar 22, 2017. The device falls under product code PNR (Enteral Syringes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 22, 2017
Date Received
Jul 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteral Syringes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type
510(k)

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

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  • K203613 — ENFit Reusable Enteral Syringe (Aug 27, 2021)
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FDA data resources