Single-use Ureteral Access Sheath— 510(k) K240167
Substantially EquivalentHunan Vathin Medical Instrument Co., Ltd.
FDA 510(k) clearance K240167 for Single-use Ureteral Access Sheath, Substantially Equivalent on 2024-10-08. Applicant: Hunan Vathin Medical Instrument Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd.
- Product code
- Code FED
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xingtan, CN
Recent devices under product code FED
view allMore 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 FED
product code FED- Death
- 10
- Total
- 10
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.