SONIC SHOT GX— 510(k) K091734

Substantially Equivalent

Nemoto Kyorindo Co., Ltd.

FDA 510(k) clearance K091734 for SONIC SHOT GX, Substantially Equivalent on 2010-05-21. Applicant: Nemoto Kyorindo Co., Ltd..

Clearance details

Applicant: Nemoto Kyorindo Co., Ltd.
Product code: Code IZQ
Advisory panel: Cardiovascular
Date received: 2009-06-11
Decision date: 2010-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kawaguchi-Shi, Saitama, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZQ

product code IZQ

Death: 7
Total: 7

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.