Cleared Traditional

ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B

K123033 · Rocket Medical Plc · Anesthesiology

Feb 2013

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K123033 is an FDA 510(k) clearance for the ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B, a Apparatus, Suction, Patient Care (Class II — Special Controls, product code DWM), submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on February 1, 2013, 126 days after receiving the submission on September 28, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5050.

Submission Details

510(k) Number	K123033 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2012
Decision Date	February 01, 2013
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF