Cleared Traditional

SUCTION INSTRUMENTATION

K972074 · Walter Lorenz Surgical, Inc. · General Hospital
Jul 1997
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K972074 is an FDA 510(k) clearance for the SUCTION INSTRUMENTATION, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 25, 1997, 52 days after receiving the submission on June 3, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K972074 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1997
Decision Date July 25, 1997
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

Similar Devices — GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 86
STRYKER CASSETTE PUMP
K042454 · Stryker Endoscopy · Dec 2004
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
K992126 · Circon Corp. · Aug 1999
CHASE SUCKER
K971022 · Chase Medical, Inc. · Apr 1997
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
K964127 · Allegiance Healthcare Corp. · Dec 1996
CURITY THORACENTESIS TRAY
K964519 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1996
STRYKER SUCTION REGULATOR
K963648 · Stryker Endoscopy · Nov 1996