510(k) K212048
- Device
- Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
- Applicant
- Intuitive Surgical, Inc.
- 510(k) number
- K212048
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-26
- Date received
- 2021-06-30
- 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
- Jennifer Siu
- Address
- 1266 Kifer Rd. Sunnyvale CA US 94086 94086
FDA Registration Numbers#
- 1000393132
- 3042172882
- 3029929134
- 1526611
- 3025349506
- 3010398867
- 3023460764
- 3015139943
- 8030673
- 3003678543
- 3033628477
- 2020550
- 3033536312
- 3011137372
- 1000484830
- 3010707607
- 3016678045
- 3022472
- 3010202439
- 3033509898
- 9614641
- 3004837686
- 8010047
- 3004142795
- 3007305485
- 3006984716
- 3004083736
- 3023809956
- 9611997
- 3042225166
- 3016096100
- 9610617
- 2011171
- 3007695959
- 3015316279
- 3013298431
- 3040391040
- 3010273867
- 1037905
- 3009420598
- 1221826
- 3013440400
- 3005987240
- 3010396739
- 3004065885
- 3003782610
- 3015970743
- 9611680
- 3008386005
- 3008439484
- 3004962788
- 3017859830
- 3010421104
- 2032112
- 3043226252
- 1000121056
- 3005465238
- 3015142721
- 1220850
- 3013557562
- 3012322232
- 3010432890
- 9610691
- 3012843412
- 3010041511
- 9710524
- 3011050570
- 3010383847
- 1721686
- 2124215
- 1833700
- 3023214418
- 3003637092
- 3021325287
- 9611102
- 2029015
- 3010280860
- 1650907
- 3025749544
- 3006621103
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#
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FDA Review#
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