K242668
- 510(k) number
- K242668
- Device name
- Gastro Concepts Air Assist
- Applicant
- Gastro Concepts, LLC DE · US
- Product code
- FER — Anoscope And Accessories
- Decision date
- 2024-12-13
- Date received
- 2024-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242668.pdf
Official FDA record: K242668
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.