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FDA 510(k)

Medline ENfit OTC Feeding Syringe

K-Number: K202285 · 2020-10-09

ApplicantMedline Industries, Inc.
Decision Date2020-10-09
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medline ENfit OTC Feeding Syringe is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2020-10-09 under approval number K202285. 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 Medline ENfit OTC Feeding Syringe?

Medline ENfit OTC Feeding Syringe is a medical device that received FDA 510(k) clearance on 2020-10-09. It is manufactured by Medline Industries, Inc.. The 510(k) number is K202285.

When was Medline ENfit OTC Feeding Syringe approved by the FDA?

Medline ENfit OTC Feeding Syringe received FDA 510(k) clearance on 2020-10-09, under approval number K202285.

What company makes Medline ENfit OTC Feeding Syringe?

Medline ENfit OTC Feeding Syringe is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline ENfit OTC Feeding Syringe?

The FDA product code for Medline ENfit OTC Feeding Syringe is PNR.

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Related Devices (Code: PNR)

K160855U&U Enteral SyringeU&U Medical Technology Co, Ltd. K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)Vr Medical Technology K161963Monoject Enteral Syringe with ENFit ConnectorCovidien 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. K160419Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien

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.

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