Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)— 510(k) K192342
Substantially EquivalentHangzhou AGS MedTech Co., Ltd.
FDA 510(k) clearance K192342 for Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories), Substantially Equivalent on 2020-05-21. Applicant: Hangzhou AGS MedTech Co., Ltd..
Clearance details
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Product code
- Code KNS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
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.