Cleared Traditional

ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS

K953432 · Midas Rex Pneumatic Tools, Inc. · General & Plastic Surgery
Sep 1995
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K953432 is an FDA 510(k) clearance for the ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS, a Motor, Surgical Instrument, Pneumatic Powered (Class I — General Controls, product code GET), submitted by Midas Rex Pneumatic Tools, Inc. (Fort Worth, US). The FDA issued a Cleared decision on September 14, 1995, 55 days after receiving the submission on July 21, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K953432 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1995
Decision Date September 14, 1995
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GET — Motor, Surgical Instrument, Pneumatic Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

Similar Devices — GET Motor, Surgical Instrument, Pneumatic Powered

All 22
AESCULAP POWER SYSTEM HANDPIECE
K960473 · Aesculap, Inc. · Mar 1996
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY
K955174 · Sodem Diffusion SA · Jan 1996
NUCLEOTOME L KIT
K942987 · Surgical Dynamics, Inc. · Oct 1995
MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS
K954076 · Midas Rex Pneumatic Tools, Inc. · Oct 1995
MIDAS REX TELESCOPING SYSTEM
K953433 · Midas Rex Pneumatic Tools, Inc. · Sep 1995
GS & GS20 SURGICAL TOOL SYSTEM
K952463 · Midas Rex Pneumatic Tools, Inc. · Jul 1995