Cleared Traditional

K021813 - HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM (FDA 510(k) Clearance)

K021813 · Hydrocision, Inc. · General Hospital

May 2003

Decision

340d

Days

Class 2

Risk

K021813 is an FDA 510(k) clearance for the HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).

Submitted by Hydrocision, Inc. (Hopkonton, US). The FDA issued a Cleared decision on May 9, 2003, 340 days after receiving the submission on June 3, 2002.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.

Submission Details

510(k) Number	K021813 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 03, 2002
Decision Date	May 09, 2003
Days to Decision	340 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF