K223499 is an FDA 510(k) clearance for the Three Way Stop Cock. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by M/S Romsons International (Noida, IN). The FDA issued a Cleared decision on July 21, 2023, 242 days after receiving the submission on November 21, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K223499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2022 |
| Decision Date | July 21, 2023 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG - Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |