FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ultramatrix EUS Balloon
K Number: K180731
·
Decision Apr 19, 2018
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
42
Applicant Total
1
Review Days
30
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Basic Information
- Device Name
- Ultramatrix EUS Balloon
- K Number
- K180731
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- United States Endoscopy Group, Inc. (Us Endoscopy)
- Date Received
- March 20, 2018
- Decision Date
- April 19, 2018
- Product Code
- ODG
- 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 |
|---|---|---|---|
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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