TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE— 510(k) K970370

Substantially Equivalent

Tsk Laboratory, Japan

FDA 510(k) clearance K970370 for TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE, Substantially Equivalent on 1997-04-10. Applicant: Tsk Laboratory, Japan.

Clearance details

Applicant: Tsk Laboratory, Japan
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1997-01-31
Decision date: 1997-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tochigi-Shi, Tochigi-Ken, JP

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.