FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
BAROnova Access Sheath Kit
K Number: K191078
·
Decision Jul 22, 2019
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- BAROnova Access Sheath Kit
- K Number
- K191078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1510
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Baronova, Inc.
- Date Received
- April 23, 2019
- Decision Date
- July 22, 2019
- Product Code
- QGG
- 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 |
|---|---|---|---|
| QGG | Esophageal Sheath With Distal Balloon Anchor | FDA class 2 | Gastroenterology, Urology |