FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hilzo Esophageal Stents
K Number: K223266
·
Decision Jan 16, 2024
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
1
Review Days
449
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Basic Information
- Device Name
- Hilzo Esophageal Stents
- K Number
- K223266
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thoracent, Inc.
- Date Received
- October 24, 2022
- Decision Date
- January 16, 2024
- Product Code
- ESW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | FDA class 2 | General, Plastic Surgery |
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