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FDA 510(k)

AirSurgN Insufflator (10030/AirSurgN)

K-Number: K242772 · 2025-04-11

ApplicantSmartsurgN, Inc.
Decision Date2025-04-11
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AirSurgN Insufflator (10030/AirSurgN) is a medical device manufactured by SmartsurgN, Inc.. It received FDA 510(k) clearance on 2025-04-11 under approval number K242772. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirSurgN Insufflator (10030/AirSurgN)?

AirSurgN Insufflator (10030/AirSurgN) is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by SmartsurgN, Inc.. The 510(k) number is K242772.

When was AirSurgN Insufflator (10030/AirSurgN) approved by the FDA?

AirSurgN Insufflator (10030/AirSurgN) received FDA 510(k) clearance on 2025-04-11, under approval number K242772.

What company makes AirSurgN Insufflator (10030/AirSurgN)?

AirSurgN Insufflator (10030/AirSurgN) is manufactured by SmartsurgN, Inc..

What is the FDA product code for AirSurgN Insufflator (10030/AirSurgN)?

The FDA product code for AirSurgN Insufflator (10030/AirSurgN) is HIF.

Other Devices by SmartsurgN, Inc.

K242163SmartSurgN Visualization System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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