The following data is part of a premarket notification filed by Torax Medical, Inc. with the FDA for Ethicon Linx Esophagus Sizing Tool.
| Device ID | K201035 |
| 510k Number | K201035 |
| Device Name: | ETHICON Linx Esophagus Sizing Tool |
| Classification | Laparoscopic Accessories, Esophageal Sizing |
| Applicant | Torax Medical, Inc. 4188 Lexington Avenue, N Shoreview, MN 55126 |
| Contact | Joseph Ciccone |
| Correspondent | Joseph Ciccone Torax Medical, Inc. 4188 Lexington Avenue, N Shoreview, MN 55126 |
| Product Code | QJN |
| CFR Regulation Number | 876.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-20 |
| Decision Date | 2020-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30855106005432 | K201035 | 000 |