K050495 is an FDA 510(k) clearance for the EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT). This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Baxter Healthcare Corp., Bioscience (Westlake Village, US). The FDA issued a Cleared decision on May 2, 2005, 63 days after receiving the submission on February 28, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K050495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2005 |
| Decision Date | May 02, 2005 |
| Days to Decision | 63 days |
| Submission Type | Special |
| 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 |