510(k) K081518
- Device
- ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
- Applicant
- PENTAX MEDICAL COMPANY
- 510(k) number
- K081518
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-05
- Date received
- 2008-05-30
- Regulation
- 874.4680
- Classification name
- Bronchoscope (flexible Or Rigid)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL SILVA
- Address
- 102 Chestnut Ridge Rd. Montvale NJ US 07645 07645
FDA Registration Numbers#
- 9614641
- 1828132
- 3014605202
- 3025349506
- 2242464
- 1037905
- 9615393
- 3014769442
- 3013666218
- 3015316279
- 3013992977
- 3017619652
- 3023460764
- 3007487007
- 3006786907
- 3006161756
- 3038613760
- 3010280860
- 3020331900
- 1320894
- 3004065885
- 3016045249
- 3017425975
- 3016555232
- 3043226252
- 3023214418
- 3008386005
- 3012627460
- 3006984716
- 3019807891
- 8010047
- 3005465238
- 3015970743
- 3009719225
- 3030504644
- 1220477
- 3015142721
- 9610691
- 3003678543
- 3013298431
- 1221826
- 3004111573
- 3015895145
- 3010396739
- 3016678045
- 3004644065
- 3006546082
- 3005369776
- 3009420598
- 3011050570
- 3035950510
- 3015153469
- 3001675293
- 3026787544
- 2020550
- 3006174295
- 3015139943
- 2183744
- 1319639
- 3012448339
- 3004142795
- 3023102955
- 3007305485
- 3013283620
- 3007867778
- 9610877
- 3014342096
- 3008439484
- 9681260
- 3017820152
- 3005099803
- 3004837686
- 3015925378
- 3022631687
- 3010493171
- 3005382983
- 3010383847
- 2030624
- 3017367014
- 3027205723
Source Documents#
Other 510(k) Records For Product Code EOQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254026 | 3.8mm 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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