Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SmartSurgN Visualization System

K-Number: K213943 · 2022-11-29

ApplicantSmartsurgn Incorporated
Decision Date2022-11-29
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 Incorporated. It received FDA 510(k) clearance on 2022-11-29 under 510(k) number K213943. 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 2022-11-29. The listed applicant is Smartsurgn Incorporated. The 510(k) number is K213943.

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

SmartSurgN Visualization System received FDA 510(k) clearance on 2022-11-29, under 510(k) number K213943.

Who is the listed applicant for SmartSurgN Visualization System?

The FDA 510(k) record lists Smartsurgn Incorporated 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 Incorporated 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 SystemK242772AirSurgN Insufflator (10030/AirSurgN)

Related Devices (Code: OWN)

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.

K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KGK251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED Light Source with AIMStryker EndoscopyK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG

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.

↑