K023917 is an FDA 510(k) clearance for the WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Kawasumi Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on February 26, 2003, 93 days after receiving the submission on November 25, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K023917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2002 |
| Decision Date | February 26, 2003 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |