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510(k) K091768

Device
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
Applicant
VISION-SCIENCES, INC.
510(k) number
K091768
Product code
EOQ  
Decision
Substantially Equivalent (SESE)
Decision date
2009-08-03
Date received
2009-06-16
Regulation
874.4680
Classification name
Bronchoscope (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
No

Applicant Contact#

Contact
LILLIAN QUINTERO
Address
40 Ramland Rd. S. Orangeburg NY US 10962 10962

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EOQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.2026-09-02
K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.2026-07-25
K254037LungFlow Airway CatheterFree Flow Medical, Inc.2026-07-10
K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation2026-06-16
K260565SmartClip Delivery Catheter (ADR-1715)Elucent Medical2026-05-14
K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.2026-04-23
K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.2026-04-08
K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation2025-12-12
K251731KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)Karl Storz SE & CO. KG2025-12-05
K251894Himaging Bronchscope SystemHimaging Technology (Shanghai) Co., Ltd.2025-09-23
K252045Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.2025-09-23
K252528Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.2025-09-05
K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.2025-08-27
K251823UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)Zhejiang UE Medical Corp.2025-08-11
K250232Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.2025-07-25

Legacy Summary#

summary

FDA Review#

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