510(k) K241731

Device
Outlook Surgical Versa One System (8900139)
Applicant
Resnent, LLC
510(k) number
K241731
Product code
EOB
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-11
Date received
2024-06-17
Regulation
874.4760
Classification name
Nasopharyngoscope (Flexible Or Rigid)
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Willard Noyes
Address
3210 Mulligan Dr. Bloomington IL US 61704 61704

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EOB

510(k)DeviceApplicantDecision date
K254133ENTity USB Videoscope SystemOptim, LLC2026-05-14
K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.2026-03-25
K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation2026-03-20
K243639Portare System (FA-001)Grumpy Innovation, Inc.2025-06-05
K243380VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)Olympus Medical Systems Corporation2025-03-03
K234096MonoStereoMedicaltek Co., Ltd.2024-09-19
K232435Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-04-26
K232015ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)Atmos Medizintechnik GmbH & Co. KG2023-08-03
K222587PatCom Distal Chip EndoscopeH&A Mui Enterprises, Inc.2023-07-28
K230536Single-use Flexible Rhinolaryngoscope; Digital Video MonitorHunan Vathin Medical Instrument Co., Ltd.2023-06-14
K221660RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XPOlympus Medical Systems Corp.2022-12-28
K221581Single-Use Flexible RhinolaryngoscopeHunan Vathin Medical Instrument Co., Ltd.2022-11-18
K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10Pentax of America, Inc.2022-11-16
K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.2022-09-19
K214050ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis)2022-07-01