Cleared Traditional

K180092 - Intellitorq
(FDA 510(k) Clearance)

K180092 · Gauthier Biomedical, Inc. · Orthopedic device

Mar 2018

Decision

55d

Days

Class 1

Risk

K180092 is an FDA 510(k) clearance for the Intellitorq. This device is classified as a Wrench (Class I - General Controls, product code HXC).

Submitted by Gauthier Biomedical, Inc. (Grafton, US). The FDA issued a Cleared decision on March 8, 2018, 55 days after receiving the submission on January 12, 2018.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K180092 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 12, 2018
Decision Date	March 08, 2018
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement