510(k) K970107
- Device
- INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
- Applicant
- UROHEALTH SYSTEMS, INC.
- 510(k) number
- K970107
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-18
- Date received
- 1997-01-13
- 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
- RONALD H BERGESON
- Address
- 3050 Redhill Ave. Costa Mesa CA US 92626 92626
FDA Registration Numbers#
- 3009171251
- 3010396739
- 3023214418
- 3010398867
- 3010041511
- 9680515
- 2242464
- 3006161756
- 3015224777
- 3029929134
- 3025349506
- 3006546082
- 2030624
- 1828132
- 8010273
- 3012322232
- 3017140456
- 3005099803
- 8030673
- 3024021261
- 3003782610
- 3007487007
- 3010280860
- 3017820152
- 3013077751
- 3010885402
- 2938071
- 3009039068
- 3013557562
- 3043226252
- 3011137372
- 3015925378
- 3017961114
- 3010707607
- 9610617
- 3010273872
- 1037955
- 3015142721
- 3014605202
- 3021031769
- 3013992977
- 3038182369
- 3038613760
- 9610595
- 9615393
- 1000484830
- 3013440400
- 1833700
- 3005369776
- 3017859830
- 3007695959
- 3013868968
- 3015136743
- 3027205723
- 3030504644
- 3013665681
- 3007738736
- 8010047
- 3009420598
- 3004962788
- 3003678543
- 8021995
- 3010684280
- 3015895145
- 3008439484
- 3020331900
- 9610691
- 3016832577
- 2183744
- 1220592
- 3004065885
- 3015316279
- 3019807891
- 3012448339
- 3011050570
- 1721686
- 1220850
- 3010432890
- 3016607092
- 3007867778
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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