FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
K Number: K234046
·
Decision Mar 8, 2024
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
15
Applicant Total
231
Review Days
78
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Basic Information
- Device Name
- WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- K Number
- K234046
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- December 21, 2023
- Decision Date
- March 8, 2024
- Product Code
- MQR
- 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 |
|---|---|---|---|
| MQR | Stent, Colonic, Metallic, Expandable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQR), ordered by most recent decision date.
WallFlex Colonic Stent System with Anchor Lock Delivery System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT LowAx Colon/Rectum (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVOLUTION COLONIC STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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