MPS (OR MPS-T)— 510(k) K041838

Name: FDA 510(k) clearance K041838
Creator: U.S. Food and Drug Administration
Published: 2005-03-01

Substantially Equivalent

Innerspace, Inc.

FDA 510(k) clearance K041838 for MPS (OR MPS-T), Substantially Equivalent on 2005-03-01. Applicant: Innerspace, Inc.. Device class: 2.

Clearance details

Applicant: Innerspace, Inc.
Product code: Code GWM
Device class: Class 2
Regulation: 21 CFR 882.1620
Advisory panel: Neurology
Date received: 2004-07-07
Decision date: 2005-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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K083378 — SYNERGY2009-09-29
K072379 — MPS OXIPORT AND MPS OXIPORT PLUS2008-04-29
K013705 — ACT III VENTRICULAR CATHETER2002-09-09
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Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.