K242211
- 510(k) number
- K242211
- Device name
- PUMA-G Pediatric System
- Applicant
- Coaptech, Inc. MD · US
- Product code
- KGC — Tube, Gastro-Enterostomy
- Decision date
- 2025-04-29
- Date received
- 2024-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K242211.pdf
Official FDA record: K242211
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.