K242901
- 510(k) number
- K242901
- Device name
- ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
- Applicant
- Tools For Surgery, LLC NY · US
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2025-01-10
- Date received
- 2024-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242901.pdf
Official FDA record: K242901
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.