Multi-Functional Electrosurgical Knife
by Anrei Medical (Hangzhou) Co., Ltd.
510(k) K212999
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212999 | Date21 Mar 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 1 Oct 2026
This device is an Electrosurgical, Endoscopic (With or Without Accessories) instrument, classified as a Class II medical device under FDA regulations. It combines electrosurgical capabilities with precision cutting to facilitate tissue dissection, coagulation, and haemostasis during surgical procedures. The knife is designed for use in minimally invasive endoscopic surgeries, particularly in gastroenterology and urology, where controlled tissue manipulation is required. Its multifunctional design allows for versatile applications in both cutting and sealing tasks, enhancing procedural efficiency.
The Multi-Functional Electrosurgical Knife is supplied sterile for single-use, adhering to FDA clearance (K212999) under the 510(k) Traditional pathway. It is intended for use in controlled surgical environments, such as operating rooms or endoscopy suites, where electrosurgical precision is required. The device is non-magnetic and MRI-safe, ensuring compatibility with magnetic resonance imaging environments when used as directed. Storage instructions specify maintaining sterility until first use, with no specified size variations beyond the standard endoscopic design referenced in the regulatory submission.
Other devices from Anrei Medical (Hangzhou) Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Multi-Functional Electrosurgical Knife used for?
The Multi-Functional Electrosurgical Knife is designed for minimally invasive endoscopic surgeries, particularly in gastroenterology and urology. It combines electrosurgical capabilities with precision cutting to perform tissue dissection, coagulation, and haemostasis. This multifunctional design allows surgeons to efficiently handle both cutting and sealing tasks during procedures, improving procedural efficiency and control.
Is the Multi-Functional Electrosurgical Knife supplied sterile and for single-use?
Yes, the Multi-Functional Electrosurgical Knife is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s performance for one surgical procedure. The sterility must be preserved until the first use, as indicated by the manufacturer’s storage instructions.
Can this device be used in an MRI environment?
Yes, the Multi-Functional Electrosurgical Knife is non-magnetic and MRI-safe. This means it can be used in controlled surgical environments where magnetic resonance imaging (MRI) may be required or performed, provided it is used as directed by the manufacturer. Always follow the device’s instructions to ensure compatibility and safety.
Are there different sizes or models available for this device?
The regulatory submission for the Multi-Functional Electrosurgical Knife does not specify any size variations beyond the standard endoscopic design. It is designed as a single, versatile model intended for endoscopic procedures in gastroenterology and urology. If specific size requirements are needed, consult the manufacturer for additional options or custom solutions.
How should the Multi-Functional Electrosurgical Knife be stored?
The device must be stored in a way that maintains its sterility until the first use. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging, protected from contamination, moisture, and physical damage. Follow the manufacturer’s storage guidelines to ensure the device remains effective and safe for use in surgical settings.