510(k) K152466
- Device
- Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
- Applicant
- PROSURG, INC
- 510(k) number
- K152466
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-19
- Date received
- 2015-08-31
- 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
- Ashvin Desai
- Address
- 2193 Trade Zone Blvd. San Jose CA US 95131 95131
FDA Registration Numbers#
- 9615393
- 3016045249
- 3005099803
- 3022631687
- 9710524
- 3012448339
- 3010383847
- 9613846
- 9611680
- 3013298431
- 1833700
- 9610691
- 3007867778
- 1650907
- 1314417
- 3004644065
- 3009171251
- 3007084728
- 2032112
- 3010280860
- 3014342096
- 3021031769
- 3042172882
- 3003782610
- 1319639
- 3017859830
- 3009420598
- 2246552
- 2029015
- 3012797688
- 3013666218
- 3015316279
- 3020746799
- 3007695959
- 3003678543
- 3006546082
- 3014769442
- 3023214418
- 3004040397
- 1000121056
- 3015142721
- 2242464
- 3017616393
- 8010273
- 1037955
- 3013283620
- 3003183807
- 3013440400
- 9681147
- 1526611
- 3015139943
- 3010707607
- 3017367014
- 9680515
- 3004837686
- 1828132
- 3015925378
- 3011416394
- 3038613760
- 3014491269
- 3042225166
- 3010273872
- 2011171
- 3022472
- 9611997
- 1721686
- 3009039068
- 8040233
- 3004065885
- 2020550
- 3023102955
- 1320894
- 3025349506
- 2243757
- 3013992977
- 8030673
- 3019807891
- 3008729892
- 3003637092
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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