Cleared Traditional

VESITEC DRILL GUIDE

K931182 · Vesitec Medical, Inc. · Orthopedic

Jun 1993

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K931182 is an FDA 510(k) clearance for the VESITEC DRILL GUIDE, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Vesitec Medical, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on June 9, 1993, 92 days after receiving the submission on March 9, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K931182 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 1993
Decision Date	June 09, 1993
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement