Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
by Hangzhou AGS MedTech Co., Ltd.
510(k) K192342
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK192342 | Date21 May 2020 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- KNS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4300
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is an electrosurgical generator with endoscopic accessories, combining a bipolar polypectomy snare and single-use electrosurgical knives. It is classified as an electrosurgical, endoscopic unit and is designed to deliver controlled electrical energy for tissue dissection, coagulation, and ablation during minimally invasive procedures. The system integrates precision cutting and sealing capabilities to support procedures in gastroenterology and urology, including polypectomy and tissue resection.
The system is supplied as a reusable generator paired with sterile, single-use accessories for disposable knives and snares. It is intended for use in MRI-safe environments, adhering to Class II regulatory standards under FDA 510(k) clearance and MDR compliance. Accessories are available in standardized sizes for compatibility with endoscopic instruments, and the device requires proper storage under manufacturer guidelines to maintain sterility and functionality. Authorizations include FDA clearance (K192342) and MDR registration.
Other devices from Hangzhou AGS MedTech Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What types of procedures is this electrosurgical system designed to assist with in the clinic?
This system is specifically designed to support minimally invasive procedures in gastroenterology and urology, such as polypectomy and tissue resection. It combines controlled electrical energy for precise tissue dissection, coagulation, and ablation, making it suitable for endoscopic applications where cutting and sealing are required.
Are the accessories for this system reusable or single-use, and how does that affect their use?
The system includes sterile, single-use accessories for the electrosurgical knives and bipolar polypectomy snare, while the generator itself is reusable. This design ensures patient safety by eliminating cross-contamination risks, as each accessory is intended for one-time use only.
What storage conditions are required to maintain the functionality and sterility of this device?
The manufacturer specifies that the device must be stored according to their guidelines to preserve sterility and functionality. Since the accessories are single-use and sterile, they should be kept in their original packaging until use, while the reusable generator should be stored in a clean, dry environment as recommended by the manufacturer.
Can this system be used in an MRI environment, and what does that mean for its compatibility?
Yes, this system is MRI-safe, meaning it can be used in environments where MRI imaging is performed. This is important for procedures where both electrosurgical intervention and MRI compatibility are required, ensuring no interference with diagnostic imaging.
What regulatory pathways has this device undergone, and what does that imply for its use?
The device has received FDA 510(k) clearance (K192342) and MDR compliance, confirming it meets regulatory standards for safety and effectiveness in the U.S. and EU markets. This implies it has undergone rigorous testing and validation for its intended uses in gastroenterology and urology procedures.