510(k) K223266
K223266 is an FDA 510(k) premarket notification submitted by Thoracent, Inc. for the device "Hilzo Esophageal Stents". The FDA issued a decision of Substantially Equivalent on January 16, 2024. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2024
- Date Received
- October 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Esophageal
- Device Class
- Class II
- Regulation Number
- 878.3610
- Review Panel
- GU
- Submission Type