Cleared Traditional

SURGIPUMP

K935763 · W.O.M. World of Medicine GmbH · General Hospital
Apr 1994
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K935763 is an FDA 510(k) clearance for the SURGIPUMP, a Withdrawal/infusion Pump (Class II — Special Controls, product code DQI), submitted by W.O.M. World of Medicine GmbH (Tucson, US). The FDA issued a Cleared decision on April 21, 1994, 146 days after receiving the submission on November 26, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1800.

Submission Details

510(k) Number K935763 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1993
Decision Date April 21, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code DQI — Withdrawal/infusion Pump
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1800

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