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510(k) K213943

SmartSurgN Visualization System by Smartsurgn Incorporated — Product Code OWN

K213943 is an FDA 510(k) premarket notification submitted by Smartsurgn Incorporated for the device "SmartSurgN Visualization System". The FDA issued a decision of Substantially Equivalent on November 29, 2022. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2022
Date Received
December 17, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

Other clearances for product code OWN

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  • K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens (February 26, 2026)
  • K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (February 13, 2026)
  • K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040) (February 12, 2026)
  • K260108 — L12 LED Light Source with AIM (February 12, 2026)
  • K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE I (November 12, 2025)
  • K243711 — Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging Sys (July 24, 2025)
  • K243591 — OPTOVISION Endoscopic Light Source Unit (February 19, 2025)
  • K241275 — Histolog® Scanner (Hardware 2.4, Software 3.3) (August 19, 2024)
  • K233333 — KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (November 21, 2023)

FDA data resources