510(k) K033225
- Device
- EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
- Applicant
- OLYMPUS OPTICAL CO., LTD.
- 510(k) number
- K033225
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-16
- Date received
- 2003-10-06
- 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
- TINA STEFFANIE-OAK
- Address
- Two Corporate Center Dr. Melville NY US 11747 11747
FDA Registration Numbers#
- 3017140456
- 3010432890
- 3001675293
- 3012322232
- 3003761012
- 3010220595
- 3016678045
- 1650907
- 3038613760
- 3016045249
- 3038182369
- 3025749544
- 3020369549
- 3004111573
- 2243757
- 3010280860
- 3042225166
- 3004644065
- 2011171
- 3012797688
- 3015139943
- 3005099803
- 3043226252
- 3008040402
- 1037905
- 3014769442
- 3011137372
- 3004040397
- 3006621103
- 9610877
- 3011050570
- 3003637092
- 9611997
- 3017859830
- 3017367014
- 3007867778
- 3026787544
- 3010041511
- 3029929134
- 3007084728
- 8040233
- 3025603301
- 1833700
- 1319639
- 2246552
- 3003183807
- 3015612252
- 1221826
- 3027205723
- 3014491269
- 3017616393
- 3006984716
- 3006161756
- 3015316279
- 3003782610
- 3008729892
- 3010273867
- 3010383847
- 3011416394
- 3025349506
- 3010396739
- 3015136743
- 2030624
- 1000484830
- 9710524
- 3007695959
- 3018094310
- 1220850
- 3023809956
- 3005382983
- 1828132
- 3013666218
- 3022631687
- 1721686
- 3010273872
- 3035710892
- 3006786907
- 3003678543
- 3009171251
Source Documents#
Other 510(k) Records For Product Code EOQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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