K240355 is an FDA 510(k) clearance for the FROG (Filter Removal of Glass). This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Carrtech Corp (Frederick, US). The FDA issued a Cleared decision on April 18, 2025, 438 days after receiving the submission on February 5, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K240355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2024 |
| Decision Date | April 18, 2025 |
| Days to Decision | 438 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 |