Cleared Traditional

CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM

K992126 · Circon Corp. · General Hospital
Aug 1999
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K992126 is an FDA 510(k) clearance for the CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Circon Corp. (Santa Barbara, US). The FDA issued a Cleared decision on August 3, 1999, 41 days after receiving the submission on June 23, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K992126 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1999
Decision Date August 03, 1999
Days to Decision 41 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

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