K251101
- 510(k) number
- K251101
- Device name
- AIRO Suction Unit (AIRO-01)
- Applicant
- Cro, LLC MT · US
- Product code
- BTA — Pump, Portable, Aspiration (Manual Or Powered)
- Decision date
- 2025-04-26
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251101.pdf
Official FDA record: K251101
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.