510(k) K230089
- Device
- ETHICON LINX® Esophagus Sizing Tool
- Applicant
- Torax Medical, Inc.
- 510(k) number
- K230089
- Product code
- QJN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-09
- Date received
- 2023-01-12
- Regulation
- 876.5360
- Classification name
- Laparoscopic Accessories, Esophageal Sizing
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Brian Godwin
- Address
- 4188 Lexington Ave., N Shoreview MN US 55126 55126
FDA Registration Numbers#
- 1450662
- 9710649
- 3008766073
- 1527736
- 3015183635
Source Documents#
Other 510(k) Records For Product Code QJN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201035 | ETHICON Linx Esophagus Sizing Tool | Torax Medical, Inc. | 2020-07-09 |