Cleared Traditional

CANNULATED DRILL BIT

K915692 · W.L. Gore & Associates, Inc. · Orthopedic
Jan 1992
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K915692 is an FDA 510(k) clearance for the CANNULATED DRILL BIT, a Bit, Drill (Class I — General Controls, product code HTW), submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on January 16, 1992, 24 days after receiving the submission on December 23, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K915692 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1991
Decision Date January 16, 1992
Days to Decision 24 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code HTW — Bit, Drill
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540