WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR— 510(k) K023917
Substantially EquivalentKawasumi 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.. Device class: 2.
Clearance details
- Applicant
- Kawasumi Laboratories, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code FPA
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- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Kawasumi Laboratories, Inc.
view all- K190485 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
- K190233 — K-Shield Advantage Port Access Infusion Set (PAIS)
- K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System
- K123344 — K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
- K100720 — K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
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, through . 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.