K231822
- 510(k) number
- K231822
- Device name
- GOLFF Sterile Anti-Fog Solution
- Applicant
- Batrik Medical Manufacturing, Inc. CA
- Product code
- OCT — Anti Fog Solution And Accessories, Endoscopy
- Decision date
- 2024-02-26
- Date received
- 2023-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K231822.pdf
Official FDA record: K231822
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.