K022415 is an FDA 510(k) clearance for the BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Waismed, Ltd. (Ra'Ananna, IL). The FDA issued a Cleared decision on October 11, 2002, 79 days after receiving the submission on July 24, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K022415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2002 |
| Decision Date | October 11, 2002 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |