K153745 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider. This device is classified as a Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (Class II - Special Controls, product code NUJ).
Submitted by Surgical Instrument Service and Savings Inc.(Dba Medline Ren (Redmond, US). The FDA issued a Cleared decision on May 2, 2016, 125 days after receiving the submission on December 29, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..
| 510(k) Number | K153745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2015 |
| Decision Date | May 02, 2016 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NUJ - Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf). |