Smart External Drain (SED) System— 510(k) K181301

Name: FDA 510(k) clearance K181301
Creator: U.S. Food and Drug Administration
Published: 2018-06-14

Substantially Equivalent

Aqueduct Critical Care, Inc.

FDA 510(k) clearance K181301 for Smart External Drain (SED) System, Substantially Equivalent on 2018-06-14. Applicant: Aqueduct Critical Care, Inc.. Device class: 2.

Clearance details

Applicant: Aqueduct Critical Care, Inc.
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 2018-05-17
Decision date: 2018-06-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Aqueduct Critical Care, Inc.

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K172759 — Smart External Drain (SED) System2017-11-14
K171586 — Smart External Drain (SED) System2017-06-30
K161605 — Smart External Drain (SED) System2016-10-27

Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.