EOB — Nasopharyngoscope (Flexible Or Rigid) Class II
FDA product code EOB covers "Nasopharyngoscope (Flexible Or Rigid)", a Class II medical device regulated under 21 CFR 874.4760. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261544 | stryker instruments | Hydro Irrigation System | June 17, 2026 |
| K254133 | optim | ENTity USB Videoscope System | May 14, 2026 |
| K253184 | zhuhai wesee meditech co | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endosco | March 25, 2026 |
| K252050 | olympus medical systems corporation | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | March 20, 2026 |
| 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 |