FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
GOLFF Sterile Anti-Fog Solution
K Number: K231822
·
Decision Feb 26, 2024
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
26
Applicant Total
1
Review Days
250
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Basic Information
- Device Name
- GOLFF Sterile Anti-Fog Solution
- K Number
- K231822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Batrik Medical Manufacturing, Inc.
- Date Received
- June 21, 2023
- Decision Date
- February 26, 2024
- Product Code
- OCT
- 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 |
|---|---|---|---|
| OCT | Anti Fog Solution And Accessories, Endoscopy | FDA class 2 | Gastroenterology, Urology |
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