ETHICON Linx Esophagus Sizing Tool
FDA 510(k) clearance K201035 · decided 2020-07-09
Clearance details
- K-number
- K201035
- Device name
- ETHICON Linx Esophagus Sizing Tool
- Applicant
- Torax Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-20
- Decision date
- 2020-07-09
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- QJN
- Device class
- 2
- Regulation number
- 876.5360
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Shoreview, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ETHICON LINX® Esophagus Sizing Tool (K230089) | Torax Medical, Inc. | 2023-02-09 |
Recalls involving this device
No recalls on record reference this clearance.