K242772
- 510(k) number
- K242772
- Device name
- AirSurgN Insufflator (10030/AirSurgN)
- Applicant
- SmartsurgN, Inc. CA · US
- Product code
- HIF — Insufflator, Laparoscopic
- Decision date
- 2025-04-11
- Date received
- 2024-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242772.pdf
Official FDA record: K242772
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.