K152743 is an FDA 510(k) clearance for the M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706). This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Microline Surgical, Inc. (Beverly, US). The FDA issued a Cleared decision on February 8, 2016, 138 days after receiving the submission on September 23, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K152743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2015 |
| Decision Date | February 08, 2016 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |