Cleared Traditional

TUBING, NONINVASIVE

K945978 · Endoscopic Technologies, Inc. · General Hospital
Jan 1995
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K945978 is an FDA 510(k) clearance for the TUBING, NONINVASIVE, a Tubing, Noninvasive (Class II — Special Controls, product code GAZ), submitted by Endoscopic Technologies, Inc. (Norcross, US). The FDA issued a Cleared decision on January 11, 1995, 34 days after receiving the submission on December 8, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K945978 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1994
Decision Date January 11, 1995
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code GAZ — Tubing, Noninvasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

Similar Devices — GAZ Tubing, Noninvasive

All 26
SUCTION/IRRIGATOR TUBING KIT
K952605 · Surgical Laser Technologies, Inc. · Sep 1995
SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES
K930512 · Core Dynamics, Inc. · Jul 1993
NORTEC CONNECTING TUBE SET
K911865 · North American Sterilization & Packaging Co. · Nov 1991
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE
K910471 · Baxter Healthcare Corp · Mar 1991
MAXI-FLOW SUCTION SET 12 FT.
K910170 · Adler Instrument Co. · Feb 1991
MAXI-FLOW SUCTION SET W/Y CONNECTOR
K910171 · Adler Instrument Co. · Feb 1991