FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpyGlass Discover Balloon Dilation Catheter
K Number: K212582
·
Decision May 6, 2022
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
231
Review Days
263
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Basic Information
- Device Name
- SpyGlass Discover Balloon Dilation Catheter
- K Number
- K212582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- August 16, 2021
- Decision Date
- May 6, 2022
- Product Code
- GCA
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCA), ordered by most recent decision date.
Disposable Stone Retrieval Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stone Retrieval Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stone Retrieval Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fusion Quattro Extraction Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tri-Ex Extraction Balloon with Multiple Sizing
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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