K201035 is an FDA 510(k) clearance for the ETHICON Linx Esophagus Sizing Tool. This device is classified as a Laparoscopic Accessories, Esophageal Sizing (Class II - Special Controls, product code QJN).
Submitted by Torax Medical, Inc. (Shoreview, US). The FDA issued a Cleared decision on July 9, 2020, 80 days after receiving the submission on April 20, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5360. To Laparoscopically Measure An Extraluminal Dimensional Parameter Of A Gastrointestinal Organ..
| 510(k) Number | K201035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2020 |
| Decision Date | July 09, 2020 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QJN - Laparoscopic Accessories, Esophageal Sizing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5360 |
| Definition | To Laparoscopically Measure An Extraluminal Dimensional Parameter Of A Gastrointestinal Organ. |