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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 the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-11-29 under 510(k) 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. The listed applicant is Medline Industries, Inc.. The 510(k) number is K160642.

When did Medline ENFit Syringe receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline ENFit Syringe?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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