EOQ — Bronchoscope (Flexible Or Rigid) Class II
Classification Details
- Product Code
- EOQ
- Device Class
- Class II
- Regulation Number
- 874.4680
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250863 | fujifilm corporation | FUJIFILM Ultrasonic Endoscope EB-710US | December 12, 2025 |
| K251731 | karl storz se and co. kg | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | December 5, 2025 |
| K251894 | himaging technology (shanghai) co | Himaging Bronchscope System | September 23, 2025 |
| K252045 | intuitive surgical | Ion Endoluminal System (IF1000) | September 23, 2025 |
| K252528 | intuitive surgical | Ion Endoluminal System (IF1000) | September 5, 2025 |
| K251752 | shanghai anqing medical instrument co | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | August 27, 2025 |
| K251823 | zhejiang ue medical | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchosco | August 11, 2025 |
| K250232 | hunan vathin medical instrument co | Vathin® Video Bronchoscope System | July 25, 2025 |
| K250862 | olympus medical systems | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEO | June 23, 2025 |
| K244017 | fujifilm corporation | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | June 13, 2025 |
| K250118 | olympus medical systems corporation | Disposable Balloon Catheter B5-2C | June 4, 2025 |
| K250957 | olympus medical systems corporation | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Dispos | May 30, 2025 |
| K243497 | shanghai anqing medical instrument co | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, | May 29, 2025 |
| K242793 | shenzhen insighters medical technology co | Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; In | May 28, 2025 |
| K243541 | contra healthcare solutions | LumiRex Bronchoscope | April 30, 2025 |
| K250210 | scivita medical technology co | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, S | March 19, 2025 |
| K242010 | shenzhen sanping image technology co | Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y- | March 14, 2025 |
| K242324 | novatech | DUTAU-NOVATECH® | February 6, 2025 |
| K243219 | auris health | MONARCH Platform (MON-000008) | January 23, 2025 |
| K242416 | hunan vathin medical instrument co | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E | January 16, 2025 |