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510(k) K232443

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

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

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  • K200963 — Halo Single-Loop Microsnare Kit (January 5, 2021)
  • K200268 — Halo™ Single-Loop Snare Kit (June 3, 2020)
  • K193507 — Merit ONE Snare System (January 17, 2020)
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