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FDA 510(k)

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle

K-Number: K181756 · 2018-12-18

ApplicantApriomed AB
Decision Date2018-12-18
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle is a medical device manufactured by Apriomed AB. It received FDA 510(k) clearance on 2018-12-18 under approval number K181756. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle?

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle is a medical device that received FDA 510(k) clearance on 2018-12-18. It is manufactured by Apriomed AB. The 510(k) number is K181756.

When was Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle approved by the FDA?

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle received FDA 510(k) clearance on 2018-12-18, under approval number K181756.

What company makes Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle?

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle is manufactured by Apriomed AB.

What is the FDA product code for Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle?

The FDA product code for Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle is FCG.

Other Devices by Apriomed AB

K193268APrioCore Plus

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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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