Rhinolaryngoscope system
FDA 510(k) K232435 · Shenzhen HugeMed Medical Technical Development Co., Ltd.
510(k) numberK232435
Submission
- Device name
- Rhinolaryngoscope system
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
Shenzhen, CN - Received
- August 14, 2023
- Decision date
- April 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
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).
Other 510(k)s with product code EOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261544 | Hydro Irrigation SystemEOB · Traditional | Stryker Instruments | 06/17/2026SE |
| K254133 | ENTity USB Videoscope SystemEOB · Traditional | Optim, LLC | 05/14/2026SE |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…EOB · Traditional | Zhuhai Wesee Meditech Co., Ltd. | 03/25/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | Olympus Medical Systems Corporation | 03/20/2026SE |
| K241731 | Outlook Surgical Versa One System (8900139)EOB · Traditional | Resnent, LLC | 08/11/2025SE |
| K243639 | Portare System (FA-001)EOB · Traditional | Grumpy Innovation, Inc. | 06/05/2025SE |
| K243380 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)EOB · Traditional | Olympus Medical Systems Corporation | 03/03/2025SE |
| K234096 | MonoStereoEOB · Traditional | Medicaltek Co., Ltd. | 09/19/2024SE |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)EOB · Traditional | Atmos Medizintechnik GmbH & Co. KG | 08/03/2023SE |
| K222587 | PatCom Distal Chip EndoscopeEOB · Traditional | H&A Mui Enterprises, Inc. | 07/28/2023SE |
More from H&A Mui Enterprises, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260892 | Suction Pump (SU-90)BTA · Traditional | 05/14/2026SE |
| K250695 | Single-use Ureteral Access SheathFED · Traditional | 07/08/2025SE |
| K241444 | Biliary Pancreaticobiliary Scope SystemFBN · Traditional | 01/21/2025SE |
| K240374 | Ureterorenoscope SystemFGB · Traditional | 05/10/2024SE |
| K231497 | Choledochoscope SystemFBN · Traditional | 03/06/2024SE |
| K231118 | Cystoscope SystemFAJ · Traditional | 11/13/2023SE |
| K222910 | Bronchoscope SystemEOQ · Traditional | 04/11/2023SE |
Questions and answers
When was Rhinolaryngoscope system cleared by the FDA?
Rhinolaryngoscope system (K232435) received a 510(k) decision of Substantially Equivalent on April 26, 2024, 256 days after the submission was received.
What is the product code of K232435?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.