510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180092Substantially Equivalent

Intellitorq

Gauthier Biomedical, Inc., Grafton WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K180092 is the FDA 510(k) clearance record for Intellitorq, a class I device, cleared for Gauthier Biomedical, Inc. on under FDA product code HXC (Wrench). FDA records list one 510(k) clearance for Gauthier Biomedical, Inc. As of , FDA records show no recalls naming K180092.

Clearance record

Decision date
Received
(55 days to decision)
Product code
HXC Wrench
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Gauthier Biomedical, Inc. 2221 Washington St., Grafton WI
510(k) summary
Statement
Third party review
No

Clearances, product code HXC

Trailing 12 months

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

FDA records show no clearances under product code HXC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HXC, 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