Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
K-Number: K181756 · 2018-12-18
Device Summary
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. The listed applicant is Apriomed AB. The 510(k) number is K181756.
When did Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle receive FDA 510(k) clearance?
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle received FDA 510(k) clearance on 2018-12-18, under 510(k) number K181756.
Who is the listed applicant for Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle?
The FDA 510(k) record lists Apriomed AB as the applicant. This does not by itself establish the device manufacturer.
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 records listing Apriomed AB as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FCG)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.