510(k) K950636
- Device
- OLYMPUS DISPOSABLE BIOPSY FORCEPS
- Applicant
- OLYMPUS AMERICA, INC.
- 510(k) number
- K950636
- Product code
- EOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-02-27
- Date received
- 1995-02-13
- 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
- BARRY E SANDS
- Address
- 4 Nevada Dr. Lake Success NY US 11042 11042
FDA Registration Numbers#
- 1650907
- 3015139943
- 3021031769
- 3010157088
- 3005987240
- 3009039068
- 1221826
- 3015142721
- 1828132
- 1220477
- 1000121056
- 3030504644
- 3043226252
- 3007695959
- 3013557562
- 3006786907
- 3012627460
- 3008040402
- 3038613760
- 3002808148
- 3015136743
- 3016678045
- 3004962788
- 9681147
- 8010047
- 3017425975
- 3012843412
- 3004065885
- 3006621103
- 3009719225
- 3004040397
- 1314417
- 3013528571
- 3007305485
- 3027205723
- 3033536312
- 1220850
- 9610691
- 9610877
- 2011171
- 3017140456
- 3020331900
- 3022631687
- 3025349506
- 2029015
- 3042940623
- 3023460764
- 3013665681
- 2938071
- 3010202439
- 3010421104
- 3029929134
- 3005099803
- 3006161756
- 9611680
- 3036756245
- 2242464
- 2244478
- 3006546082
- 9614641
- 1223925
- 3017859830
- 8010273
- 3009171251
- 3013868968
- 3013298431
- 3016607092
- 3013077751
- 3007084728
- 9613846
- 3013283620
- 3026787544
- 3024021261
- 3003678543
- 3020746799
- 3010220595
- 3006984716
- 3005382983
- 3021325287
Source Documents#
Other 510(k) Records For Product Code EOQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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