510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925741Substantially Equivalent

Clarus Endoscopic Hook Knife

Clarus Medical Systems, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925741 is the FDA 510(k) clearance record for CLARUS ENDOSCOPIC HOOK KNIFE, a class II device, cleared for Clarus Medical Systems, Inc. on under FDA product code HLX (Photostimulator, Ac-Powered). FDA records list 22 510(k) clearances for Clarus Medical Systems, Inc., from to . As of , FDA records show no recalls naming K925741.

Clearance record

Decision date
Received
(284 days to decision)
Product code
HLX Photostimulator, Ac-Powered
Regulation
21 CFR 886.1630
Device class
Class II
Review panel
Ophthalmic
Applicant
Clarus Medical Systems, Inc. 2605 Fernbrook La, Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code HLX

Trailing 12 months

FDA records hold no clearances under product code HLX in the trailing twelve months.

FDA records show no clearances under product code HLX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HLX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260