510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223615Substantially Equivalent

Digital ClarusScope System, Digital NeuroPEN System

Clarus Medical, LLC, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223615 is the FDA 510(k) clearance record for Digital ClarusScope System, Digital NeuroPEN System, a class II device, cleared for Clarus Medical, LLC on under FDA product code GWG (Endoscope, Neurological). FDA's definition for product code GWG reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 10 510(k) clearances for Clarus Medical, LLC, from to . As of , FDA records show no recalls naming K223615.

Clearance record

Decision date
Received
(351 days to decision)
Product code
GWG Endoscope, Neurological
Regulation
21 CFR 882.1480
Device class
Class II
Review panel
Neurology
Applicant
Clarus Medical, LLC 13355 10th Ave. N Suite 110, Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWG

Trailing 12 months
2 clearances under product code GWG in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260