510(k) K150951
- Device
- Aeris Balloon Dialation Catheter
- Applicant
- Bryan Medical , Inc.
- 510(k) number
- K150951
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-06-25
- Date received
- 2015-04-09
- 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#
- Contact
- ANDY BLACK
- Address
- 3906 Oak St. Cincinnati OH US 45227 45227
FDA Registration Numbers#
- 3016548968
- 1721676
- 3013557562
- 3013152301
- 9710524
- 3008058134
- 1651395
- 3014749926
- 3003678543
- 1047843
- 3012422952
- 3005803389
- 9616684
- 3013440400
- 8010047
- 9611102
- 3002807314
- 3013517171
- 3004837686
- 9681260
- 1928237
- 1320894
- 3014579161
- 3015309643
- 9614641
- 3002907620
- 1223925
- 2183446
- 3005099803
- 3012042439
- 8040233
- 3003477135
- 3013023255
- 3011050570
- 3015980719
- 3007305485
- 3005423519
- 3010188783
- 3015970743
- 3012266672
- 1018470
- 3012536737
- 3008797804
- 1000121056
- 3010273872
- 1820334
- 3007695959
- 3005172759
- 3008040402
- 1724474
- 3021230784
- 3012494290
- 3033589330
- 3026787544
- 3042970803
- 3015225571
- 3003418325
- 3014769442
- 1721504
- 3008087383
- 2183744
- 3006950086
- 1043729
- 3003790304
Source Documents#
Other 510(k) Records For Product Code EOQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2025-09-23 |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | 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 |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | 2025-06-13 |
| K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation | 2025-06-04 |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | Olympus Medical Systems Corporation | 2025-05-30 |
Legacy Summary#
summary
FDA Review#
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