Single-Use Flexible Rhinolaryngoscope— 510(k) K221581
Substantially EquivalentHunan Vathin Medical Instrument Co., Ltd.
FDA 510(k) clearance K221581 for Single-Use Flexible Rhinolaryngoscope, Substantially Equivalent on 2022-11-18. Applicant: Hunan Vathin Medical Instrument Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiangtan, CN
Recent devices under product code EOB
view all- K261544 — Hydro Irrigation System
- K254133 — ENTity USB Videoscope System
- K253184 — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
- K241731 — Outlook Surgical Versa One System (8900139)
More clearances from Hunan Vathin Medical Instrument Co., Ltd.
view all- K250232 — Vathin® Video Bronchoscope System
- K251599 — Single-use Ureteral Access Sheath
- K250785 — Single-use Flexible Ureteroscope
- K243117 — Digital Video Processor
- K242416 — Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12 +2 more
Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.