K222846
- 510(k) number
- K222846
- Device name
- AMT G-Tube Balloon Gastrostomy Feeding Device
- Applicant
- Applied Medical Technology, Inc. OH · US
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2023-12-18
- Date received
- 2022-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K222846.pdf
Official FDA record: K222846
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.