SYNERGY— 510(k) K083378

Name: FDA 510(k) clearance K083378
Creator: U.S. Food and Drug Administration
Published: 2009-09-29

Substantially Equivalent

Innerspace, Inc.

FDA 510(k) clearance K083378 for SYNERGY, Substantially Equivalent on 2009-09-29. 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: 2008-11-14
Decision date: 2009-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)2024-02-04
K201989 — B4C System2021-10-08

More clearances from Innerspace, Inc.

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K113088 — HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)2012-05-02
K072379 — MPS OXIPORT AND MPS OXIPORT PLUS2008-04-29
K041838 — MPS (OR MPS-T)2005-03-01
K013705 — ACT III VENTRICULAR CATHETER2002-09-09
K013005 — ACT 11 MP VENTRICULAR CATHETER2002-03-08

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.