510(k) K122535
- Device
- FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
- Applicant
- FUJIFILM MEDICAL SYSTEM U.S.A., INC.
- 510(k) number
- K122535
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-12-13
- Date received
- 2012-08-20
- 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
- Yes
Applicant Contact#
- Address
- 10 High Pt. Dr. Wayne NJ US 07470 07470
FDA Registration Numbers#
- 3008309062
- 3016096100
- 3019807891
- 9611680
- 2242464
- 3013868968
- 3009719225
- 3042940623
- 1319639
- 3018094310
- 1000393132
- 3042225166
- 3005465238
- 1037955
- 3013283620
- 8010047
- 3017619652
- 9681260
- 3014247261
- 2243757
- 3014605202
- 3006621103
- 3017425975
- 3011063460
- 1526611
- 9611997
- 3004065885
- 3023809956
- 3007695959
- 3007487007
- 3025349506
- 3006786907
- 3014663814
- 3038613760
- 3029929134
- 3025749544
- 3015316279
- 3010398867
- 3003637092
- 3006174295
- 3010273867
- 3015224777
- 3015970743
- 9615393
- 3010684280
- 3017859830
- 3003183807
- 9680515
- 3040391040
- 3015139943
- 3002808148
- 3017140456
- 9681147
- 1000121056
- 3015895145
- 3030504644
- 8010273
- 3015142721
- 3013528571
- 3014491269
- 3017616393
- 3010432890
- 3007738736
- 3010220595
- 3021325287
- 3004111573
- 3006546082
- 3036756245
- 3015612252
- 3009420598
- 3004142795
- 3004837686
- 3033628477
- 3012322232
- 9710524
- 3006161756
- 3022631687
- 3015153469
- 3011416394
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 |
| K250862 | 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) | Olympus Medical Systems Corp. | 2025-06-23 |
Legacy Summary#
summary
FDA Review#
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