K172097 is an FDA 510(k) clearance for the Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves. This device is classified as a Laparoscope, General & Plastic Surgery, Reprocessed (Class II - Special Controls, product code NLM).
Submitted by Renovo, Inc. (Bend, US). The FDA issued a Cleared decision on October 6, 2017, 87 days after receiving the submission on July 11, 2017.
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 | K172097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2017 |
| Decision Date | October 06, 2017 |
| Days to Decision | 87 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). |