510(k) K201035
K201035 is an FDA 510(k) premarket notification submitted by Torax Medical, Inc. for the device "ETHICON Linx Esophagus Sizing Tool". The FDA issued a decision of Substantially Equivalent on July 9, 2020. The device falls under product code QJN (Laparoscopic Accessories, Esophageal Sizing), a Class II device regulated under 21 CFR 876.5360. Torax Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2020
- Date Received
- April 20, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscopic Accessories, Esophageal Sizing
- Device Class
- Class II
- Regulation Number
- 876.5360
- Review Panel
- GU
- Submission Type
To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ.