Cleared Traditional

K242772 - AirSurgN Insufflator (10030/AirSurgN) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242772 · Smartsurgn, Inc. · Obstetrics & Gynecology device
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Apr 2025
Decision
210d
Days
Class 2
Risk

K242772 is an FDA 510(k) clearance for the AirSurgN Insufflator (10030/AirSurgN). Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Smartsurgn, Inc. (San Jose, US). The FDA issued a Cleared decision on April 11, 2025 after a review of 210 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Smartsurgn, Inc. devices

Submission Details

510(k) Number K242772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2024
Decision Date April 11, 2025
Days to Decision 210 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 160d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 176
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K242772.
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VereSee Optical Veres Needle System
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EVA15 insufflator
K232902 · Palliare , Ltd. · May 2024