EOB
- Product code
- EOB
- Device name
- Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.4760
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 162 (all years; only the last 3 years are listed here)
FDA classification 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).
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261544 | 2026-06-17 | Stryker Instruments | Hydro Irrigation System | |
| K254133 | 2026-05-14 | Optim, LLC | ENTity USB Videoscope System | |
| K253184 | 2026-03-25 | Zhuhai Wesee Meditech Co., Ltd. | Video Rhinolaryngoscope System (Disposable Video Rhi… | FDA |
| K252050 | 2026-03-20 | Olympus Medical Systems Corporation | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D,… | |
| K241731 | 2025-08-11 | Resnent, LLC | Outlook Surgical Versa One System (8900139) | |
| K243639 | 2025-06-05 | Grumpy Innovation, Inc. | Portare System (FA-001) | |
| K243380 | 2025-03-03 | Olympus Medical Systems Corporation | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMP… | |
| K234096 | 2024-09-19 | Medicaltek Co., Ltd. | MonoStereo | — |
| K232435 | 2024-04-26 | Shenzhen HugeMed Medical Technical Dev… | Rhinolaryngoscope system |
Official FDA classification page: EOB
Classification and pathway per current FDA publications. Data from openFDA (CC0).