510(k) K232443

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

K232443 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 September 7, 2023. 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
September 7, 2023
Date Received
August 14, 2023
Clearance Type
Special
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