AirSurgN Insufflator (10030/AirSurgN)— 510(k) K242772

Substantially Equivalent

SmartsurgN, Inc.

FDA 510(k) clearance K242772 for AirSurgN Insufflator (10030/AirSurgN), Substantially Equivalent on 2025-04-11. Applicant: SmartsurgN, Inc..

Clearance details

Applicant: SmartsurgN, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2024-09-13
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.