510(k) K250862
- Device
- EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
- Applicant
- Olympus Medical Systems Corp.
- 510(k) number
- K250862
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-23
- Date received
- 2025-03-21
- 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
- Tamada Osamu
- Address
- 2951 Ishikawa-Cho Hachioji-Shi Tokyo JP 192-8507 192-8507
FDA Registration Numbers#
- 1223925
- 3004142795
- 3016607092
- 3017140456
- 3013557562
- 3005369776
- 3024021261
- 3003637092
- 3007305485
- 3020331900
- 3029929134
- 3012494290
- 3010157088
- 3011063460
- 9610617
- 2020550
- 1319639
- 9710524
- 9611680
- 3021031769
- 3036756245
- 3007867778
- 2124215
- 3012627460
- 3009420598
- 3017859830
- 9611102
- 8040233
- 9610691
- 9614641
- 3030504644
- 3007695959
- 1721686
- 1220477
- 3012797688
- 3010383847
- 8030673
- 3003678543
- 3023809956
- 1526611
- 3020369549
- 3015970743
- 9681147
- 3011050570
- 1221826
- 8010273
- 9611997
- 3013283620
- 3016555232
- 3014663814
- 3010202439
- 3033628477
- 3009719225
- 3008386005
- 3011137372
- 3012448339
- 1828132
- 3044186618
- 3015224777
- 3013298431
- 3008040402
- 3010280860
- 3023102955
- 3015895145
- 3016045249
- 2244478
- 3010273872
- 3008439484
- 3004837686
- 1650907
- 3042940623
- 3004065885
- 3015136743
- 3023460764
- 3010684280
- 3027205723
- 2938071
- 3015142721
- 3013528571
- 3014635169
Source Documents#
Other 510(k) Records For Product Code EOQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260382 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2026-07-25 |
| K254037 | LungFlow Airway Catheter | Free Flow Medical, Inc. | 2026-07-10 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Fujifilm Corporation | 2026-06-16 |
| K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | 2026-05-14 |
| K252341 | EVIS 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 |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | MacroLux Medical Technology Co., Ltd. | 2026-04-08 |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | 2025-12-12 |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | 2025-12-05 |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | 2025-09-23 |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2025-09-23 |
| K252528 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2025-09-05 |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-08-27 |
| K251823 | UE 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 |
| K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-25 |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | 2025-06-13 |