FDA.report

510(k) K242163

Device
SmartSurgN Visualization System
Applicant
SmartsurgN, Inc.
510(k) number
K242163
Product code
OWN
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-20
Date received
2024-07-24
Regulation
876.1500
Classification name
Confocal Optical Imaging
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jocelyn Long
Address
1038 Leigh Ave. Suite 101b San Jose CA US 95126 95126

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OWN

510(k)DeviceApplicantDecision date
K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG2026-02-26
K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.2026-02-13
K260108L12 LED Light Source with AIMStryker Endoscopy2026-02-12
K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG2026-02-12
K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)Olympus Medical Systems Corp.2025-11-12
K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);Wuxi Hisky Medical Technologies Co., Ltd.2025-07-24
K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC2025-02-19
K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA2024-08-19
K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG2023-11-21
K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG2023-11-06
K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker2023-09-20
K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.2023-08-02
K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.2023-07-17
K230754L12 LED Light Source with AIMStryker2023-04-11
K213943SmartSurgN Visualization SystemSmartsurgn Incorporated2022-11-29