K240961 is an FDA 510(k) clearance for the Disposable Pen Injector Assembly. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Wuxi Nest Biotechnology Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on August 15, 2024, 129 days after receiving the submission on April 8, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K240961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2024 |
| Decision Date | August 15, 2024 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |