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FDA 510(k)

Medline ENFit Syringe

K-Number: K160642 · 2016-11-29

ApplicantMedline Industries, Inc.
Decision Date2016-11-29
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medline ENFit Syringe is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-11-29 under approval number K160642. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ENFit Syringe?

Medline ENFit Syringe is a medical device that received FDA 510(k) clearance on 2016-11-29. It is manufactured by Medline Industries, Inc.. The 510(k) number is K160642.

When was Medline ENFit Syringe approved by the FDA?

Medline ENFit Syringe received FDA 510(k) clearance on 2016-11-29, under approval number K160642.

What company makes Medline ENFit Syringe?

Medline ENFit Syringe is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline ENFit Syringe?

The FDA product code for Medline ENFit Syringe is PIF.

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Related Devices (Code: PIF)

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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.

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