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

Name: FDA 510(k) clearance K242772
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Substantially Equivalent

SmartsurgN, Inc.

FDA 510(k) clearance K242772 for AirSurgN Insufflator (10030/AirSurgN), Substantially Equivalent on 2025-04-11. Applicant: SmartsurgN, Inc.. Device class: 2.

Clearance details

Applicant: SmartsurgN, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
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 ↗

Recent devices under product code HIF

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K260209 — ENDOFLATOR+; Smart Smoke Evacuation2026-08-19
K252584 — Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)2026-06-25
K252318 — Insufflator (OPTO-IFL1000)2026-04-16
K250388 — ENDOFLATOR +2025-09-22
K243527 — High Flow Insufflation Unit (UHI-4)2025-01-13

More clearances from SmartsurgN, Inc.

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K242163 — SmartSurgN Visualization System2026-04-20

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.