EOB — Nasopharyngoscope (Flexible Or Rigid) Class II
Classification Details
- Product Code
- EOB
- Device Class
- Class II
- Regulation Number
- 874.4760
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
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 |
|---|---|---|---|
| K241731 | resnent | Outlook Surgical Versa One System (8900139) | August 11, 2025 |
| K243639 | grumpy innovation | Portare System (FA-001) | June 5, 2025 |
| K243380 | olympus medical systems corporation | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | March 3, 2025 |
| K234096 | medicaltek co | MonoStereo | September 19, 2024 |
| K232435 | shenzhen hugemed medical technical development co | Rhinolaryngoscope system | April 26, 2024 |
| K232015 | atmos medizintechnik gmbh and co. kg | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507. | August 3, 2023 |
| K222587 | h and a mui enterprises | PatCom Distal Chip Endoscope | July 28, 2023 |
| K230536 | hunan vathin medical instrument co | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | June 14, 2023 |
| K221660 | olympus medical systems | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | December 28, 2022 |
| K221581 | hunan vathin medical instrument co | Single-Use Flexible Rhinolaryngoscope | November 18, 2022 |
| K220465 | pentax of america | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical | November 16, 2022 |
| K221638 | olympus medical systems | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | September 19, 2022 |
| K214050 | medimaging integrated solution, inc (miis) | ENT Nasopharyngoscope and Accessories | July 1, 2022 |
| K220004 | zsquare | Zsquare ENT-Flex Endoscope | June 14, 2022 |
| K202727 | 3nt medical | Peregrine Endoscopy System | July 23, 2021 |
| K200609 | optim | ENTity WiFi Video Nasopharyngoscope System | January 13, 2021 |
| K200740 | karl storz endoscopy-america | HD Video Rhino Laryngoscope | August 11, 2020 |
| K192305 | 3nt medical | Colibri Endoscopy System | February 27, 2020 |
| K192090 | karl storz se and co. kg | CMOS Video Rhino-Laryngoscope SSU | January 27, 2020 |
| K183416 | olympus medical systems | Rhino-Laryngo Videoscope Olympus ENF-VT3 | September 6, 2019 |