K160740 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology. This device is classified as a Laparoscope, General & Plastic Surgery, Reprocessed (Class II - Special Controls, product code NLM).
Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on May 6, 2016, 50 days after receiving the submission on March 17, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. This Device Is Indicated For Reuse/reprocessing. 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 | K160740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2016 |
| Decision Date | May 06, 2016 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NLM — Laparoscope, General & Plastic Surgery, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. This Device Is Indicated For Reuse/reprocessing. 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). |