510(k) K161656
- Device
- Ambu AScope 3 Regular 5.0/2.2, Ambu AScope 3 Slim 3.8/1.2, Ambu AScope 3 Large 5.8/2.8, Ambu AView Monitor
- Applicant
- AMBU A/S
- 510(k) number
- K161656
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-09-01
- Date received
- 2016-06-16
- Regulation
- 874.4680
- Classification name
- Bronchoscope (flexible Or Rigid)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAMILLA WISMAR
- Address
- Baltorpbakken 13 Ballerup DK DK-2750 DK-2750
FDA Registration Numbers#
- 1526611
- 3025349506
- 3018094310
- 3013298431
- 3003183807
- 2242464
- 1223925
- 3016555232
- 8010273
- 1220592
- 1650907
- 8010047
- 3005382983
- 1000484830
- 3015612252
- 2029015
- 3012322232
- 3019807891
- 2243757
- 2244478
- 3007695959
- 3015136743
- 3010707607
- 3004142795
- 9615393
- 3004962788
- 3026606306
- 1314417
- 3010398867
- 3011063460
- 1221485
- 3003637092
- 8021995
- 3003782610
- 3008439484
- 3004837686
- 3004111573
- 3002808148
- 3043226252
- 3011137372
- 3033509898
- 3017820152
- 3006621103
- 2246552
- 3006786907
- 3003761012
- 3014635169
- 3022472
- 3007867778
- 3013665681
- 1320894
- 9610877
- 3013666218
- 3024021261
- 3012448339
- 1221826
- 3042225166
- 3006984716
- 1037905
- 3020369549
- 3007738736
- 3010684280
- 3016678045
- 3011050570
- 3036756245
- 9610617
- 3010396739
- 1220850
- 1000121056
- 8040233
- 3009039068
- 3013992977
- 3027205723
- 3016607092
- 3010202439
- 9610691
- 3010493171
- 3015142721
- 3009420598
- 3009719225
Source Documents#
Other 510(k) Records For Product Code EOQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261637 | Single-use Flexible Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2026-09-23 |
| K260309 | Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | 2026-09-16 |
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | Flexicare Medical Limited. | 2026-09-02 |
| 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 |
Legacy Summary#
summary
FDA Review#
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