510(k) K191758

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit by Argon Medical Devices, Inc. — Product Code MMX

K191758 is an FDA 510(k) premarket notification submitted by Argon Medical Devices, Inc. for the device "Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit". The FDA issued a decision of Substantially Equivalent on December 17, 2019. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Argon Medical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2019
Date Received
July 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous Retrieval
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type