FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
K Number: K233939
·
Decision Apr 29, 2024
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
58
Review Days
137
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Basic Information
- Device Name
- Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
- K Number
- K233939
- 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
- Boston Scientific
- Date Received
- December 14, 2023
- Decision Date
- April 29, 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 |
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
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FDA Class 2
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HANAROSTENT Esophagus Upper (CCC)
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·General, Plastic Surgery
Resilience Fully Covered Esophageal Stent System
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FDA Class 2
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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
Hilzo Esophageal Stents
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Boston Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | Apr 8, 2026 | Substantially Equivalent |
| K252910 | Orca Air/Water and Suction Valves | Oct 9, 2025 | Unknown |
| K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Jul 3, 2025 | Substantially Equivalent |
| K250468 | iSLEEVE Introducer Set | Mar 20, 2025 | Substantially Equivalent |
| K242950 | WallFlex Biliary PLUS RX Stent System | Dec 6, 2024 | Unknown |
| K242507 | OBSIDIO Conformable Embolic | Oct 3, 2024 | Substantially Equivalent |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | Aug 30, 2024 | Unknown |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Mar 13, 2024 | Substantially Equivalent |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Nov 28, 2023 | Substantially Equivalent |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | Nov 22, 2023 | Substantially Equivalent |