K981853 is an FDA 510(k) clearance for the BONE INJECTION GUN (B.I.G.) DEVICE. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Waismed, Ltd. (Ginot Shomron 44853, IL). The FDA issued a Cleared decision on November 17, 1998, 175 days after receiving the submission on May 26, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K981853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1998 |
| Decision Date | November 17, 1998 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |