Cleared Traditional

STRYKER SUCTION REGULATOR

K963648 · Stryker Endoscopy · General Hospital
Nov 1996
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K963648 is an FDA 510(k) clearance for the STRYKER SUCTION REGULATOR, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on November 26, 1996, 75 days after receiving the submission on September 12, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K963648 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1996
Decision Date November 26, 1996
Days to Decision 75 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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