K040148 is an FDA 510(k) clearance for the RESOLUTION HEMOSTASIS CLIPPING DEVICE. This device is classified as a Clip, Hemostatic (Class II - Special Controls, product code MCH).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on April 22, 2004, 90 days after receiving the submission on January 23, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K040148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2004 |
| Decision Date | April 22, 2004 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MCH — Clip, Hemostatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |