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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 the device name listed in this FDA 510(k) record. The listed applicant is SmartsurgN, Inc.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) 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. The listed applicant is SmartsurgN, Inc.. The 510(k) number is K242772.

When did AirSurgN Insufflator (10030/AirSurgN) receive FDA 510(k) clearance?

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

Who is the listed applicant for AirSurgN Insufflator (10030/AirSurgN)?

The FDA 510(k) record lists SmartsurgN, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing SmartsurgN, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242163SmartSurgN Visualization SystemK213943SmartSurgN Visualization System

Related Devices (Code: HIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona GroupK232902EVA15 insufflatorPalliare , Ltd.

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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