Cleared Traditional

ETHICON DRILL BIT AND DRILL GUIDE

K944590 · Ethicon, Inc. · Orthopedic

May 1995

Decision

234d

Days

Class 1

Risk

About This 510(k) Submission

K944590 is an FDA 510(k) clearance for the ETHICON DRILL BIT AND DRILL GUIDE, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 11, 1995, 234 days after receiving the submission on September 19, 1994. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K944590 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 1994
Decision Date	May 11, 1995
Days to Decision	234 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820