Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm— 510(k) K150253

Substantially Equivalent

Taiwan Surgical Corporation

FDA 510(k) clearance K150253 for Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm, Substantially Equivalent on 2015-04-01. Applicant: Taiwan Surgical Corporation.

Clearance details

Applicant: Taiwan Surgical Corporation
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2015-02-03
Decision date: 2015-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhubei City, TW

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.