ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B— 510(k) K123033

Name: FDA 510(k) clearance K123033
Creator: U.S. Food and Drug Administration
Published: 2013-02-01

Substantially Equivalent

Rocket Medical Plc

FDA 510(k) clearance K123033 for ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B, Substantially Equivalent on 2013-02-01. Applicant: Rocket Medical Plc. Device class: 2.

Clearance details

Applicant: Rocket Medical Plc
Product code: Code DWM
Device class: Class 2
Regulation: 21 CFR 870.5050
Advisory panel: Cardiovascular
Date received: 2012-09-28
Decision date: 2013-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, Tyne & Wear, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWM

product code DWM

Death: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.