Single-Use Flexible Rhinolaryngoscope
FDA 510(k) K221581 · Hunan Vathin Medical Instrument Co., Ltd.
510(k) numberK221581
Submission
- Device name
- Single-Use Flexible Rhinolaryngoscope
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd.
Xiangtan, CN - Received
- June 1, 2022
- Decision date
- November 18, 2022
- 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).
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|---|---|---|---|
| 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 |
| K232435 | Rhinolaryngoscope systemEOB · Traditional | Shenzhen HugeMed Medical Technical Development… | 04/26/2024SE |
| 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 |
More from Atmos Medizintechnik GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K250232 | Vathin® Video Bronchoscope SystemEOQ · Traditional | 07/25/2025SE |
| K251599 | Single-use Ureteral Access SheathFED · Special | 07/03/2025SE |
| K250785 | Single-use Flexible UreteroscopeFGB · Traditional | 05/06/2025SE |
| K243117 | Digital Video ProcessorFGB · Traditional | 01/29/2025SE |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…EOQ · Traditional | 01/16/2025SE |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…FAJ · Traditional | 12/18/2024SE |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…EOQ · Traditional | 10/29/2024SE |
| K240167 | Single-use Ureteral Access SheathFED · Traditional | 10/08/2024SE |
| K241434 | Video Ureteroscope SystemFGB · Special | 10/04/2024SE |
| K231135 | Video Ureteroscope SystemFGB · Traditional | 01/17/2024SE |
Questions and answers
When was Single-Use Flexible Rhinolaryngoscope cleared by the FDA?
Single-Use Flexible Rhinolaryngoscope (K221581) received a 510(k) decision of Substantially Equivalent on November 18, 2022, 170 days after the submission was received.
What is the product code of K221581?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.