Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tamper Evident Cap For use with ENFit Syringes

K-Number: K170672 · 2017-10-06

ApplicantInternational Medical Industries, Inc.
Decision Date2017-10-06
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tamper Evident Cap For use with ENFit Syringes is a medical device manufactured by International Medical Industries, Inc.. It received FDA 510(k) clearance on 2017-10-06 under approval number K170672. 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 Tamper Evident Cap For use with ENFit Syringes?

Tamper Evident Cap For use with ENFit Syringes is a medical device that received FDA 510(k) clearance on 2017-10-06. It is manufactured by International Medical Industries, Inc.. The 510(k) number is K170672.

When was Tamper Evident Cap For use with ENFit Syringes approved by the FDA?

Tamper Evident Cap For use with ENFit Syringes received FDA 510(k) clearance on 2017-10-06, under approval number K170672.

What company makes Tamper Evident Cap For use with ENFit Syringes?

Tamper Evident Cap For use with ENFit Syringes is manufactured by International Medical Industries, Inc..

What is the FDA product code for Tamper Evident Cap For use with ENFit Syringes?

The FDA product code for Tamper Evident Cap For use with ENFit Syringes is PNR.

Other Devices by International Medical Industries, Inc.

K173577Guarded Luer Connector K190305Additive Cap K182545Tamper Evident Cap with Male Luer Lock K201031NRFit® Caps, Male and Female Neuraxial Tip Caps K193192Tamper Evident Cap K231095Tamper Evident Cap

View all 7 devices →

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.

↑