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FDA 510(k)

SmartSurgN Visualization System

K-Number: K242163 · 2026-04-20

ApplicantSmartsurgN, Inc.
Decision Date2026-04-20
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SmartSurgN Visualization System is the device name listed in this FDA 510(k) record. The listed applicant is SmartsurgN, Inc.. It received FDA 510(k) clearance on 2026-04-20 under 510(k) number K242163. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartSurgN Visualization System?

SmartSurgN Visualization System is a medical device that received FDA 510(k) clearance on 2026-04-20. The listed applicant is SmartsurgN, Inc.. The 510(k) number is K242163.

When did SmartSurgN Visualization System receive FDA 510(k) clearance?

SmartSurgN Visualization System received FDA 510(k) clearance on 2026-04-20, under 510(k) number K242163.

Who is the listed applicant for SmartSurgN Visualization System?

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 SmartSurgN Visualization System?

The FDA product code for SmartSurgN Visualization System is OWN.

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.

K242772AirSurgN Insufflator (10030/AirSurgN)K213943SmartSurgN Visualization System

Related Devices (Code: OWN)

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Official Source

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