FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WALLSTENT ESOPHAGEAL PROTHESIS
K Number: K923119
·
Decision Sep 1, 1992
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
3
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- WALLSTENT ESOPHAGEAL PROTHESIS
- K Number
- K923119
- 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
- Schneider U.S. Stent Div.
- Date Received
- June 26, 1992
- Decision Date
- September 1, 1992
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESW), ordered by most recent decision date.
Niti-S Esophageal Stent; Esophageal TTS Stent
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT Esophagus Upper (CCC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Resilience Fully Covered Esophageal Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Agile Esophageal Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Esophageal TTS Stent
FDA 510(k)
FDA Class 2
·General, Plastic Surgery