WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR— 510(k) K023917

Substantially Equivalent

Kawasumi Laboratories, Inc.

FDA 510(k) clearance K023917 for WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR, Substantially Equivalent on 2003-02-26. Applicant: Kawasumi Laboratories, Inc..

Clearance details

Applicant: Kawasumi Laboratories, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2002-11-25
Decision date: 2003-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.