ENFit Reusable Enteral Syringe
K-Number: K203613 · 2021-08-27
Decision Date2021-08-27
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ENFit Reusable Enteral Syringe is a medical device manufactured by Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2021-08-27 under approval number K203613. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ENFit Reusable Enteral Syringe?
ENFit Reusable Enteral Syringe is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K203613.
When was ENFit Reusable Enteral Syringe approved by the FDA?
ENFit Reusable Enteral Syringe received FDA 510(k) clearance on 2021-08-27, under approval number K203613.
What company makes ENFit Reusable Enteral Syringe?
ENFit Reusable Enteral Syringe is manufactured by Shantou Wealy Medical Instrument Co.,Ltd.
What is the FDA product code for ENFit Reusable Enteral Syringe?
The FDA product code for ENFit Reusable Enteral Syringe is PNR.
Other Devices by Shantou Wealy Medical Instrument Co.,Ltd
Related Devices (Code: PNR)
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K161045MonojectCovidien
K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)Neomed, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.