INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES - Insulation And Continuity Tester Plus Accessories
510(k) K020334
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020334 | Date3 Oct 2002 | 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- Withdrawn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
- GEI
- Models / Variants
- Insulation And Continuity Tester Plus Accessories
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Insulation and Continuity Tester Plus Accessories (Models ATI014 & ATI014 FC) is a battery-operated, rechargeable device classified under Electrosurgical, Cutting & Coagulation & Accessories (Product Code GEI). It is designed to verify the insulation integrity and electrical continuity of electrosurgical instruments, ensuring safe operation before surgical procedures. This tester helps prevent electrical hazards by confirming that insulation remains intact and that conductive pathways function correctly.
Used primarily in pre-operative settings, this device is intended for single-use or reusable applications, depending on manufacturer guidelines. It operates in non-sterile environments and is not intended for MRI use. The tester is supplied with accessories for testing various electrosurgical instruments and is authorized under FDA 510(k) clearance (K020334). Storage and handling follow standard electrical safety protocols to maintain functionality and reliability.
Other devices from Jac-Cell Medic Corporation
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the Insulation and Continuity Tester Plus Accessories (Models ATI014 & ATI014 FC) in a surgical setting?
This device is designed to verify the insulation integrity and electrical continuity of electrosurgical instruments before surgical procedures. By confirming that insulation remains intact and conductive pathways function correctly, it helps prevent electrical hazards, ensuring safe operation during surgery.
Can the Insulation and Continuity Tester Plus be used in a sterile environment, and what are its storage requirements?
The tester is explicitly designed for use in non-sterile environments, such as pre-operative settings. Storage and handling should follow standard electrical safety protocols to maintain functionality and reliability, as it is not intended for direct sterile field use.
Are the Insulation and Continuity Tester Plus Accessories (Models ATI014 & ATI014 FC) intended for single-use or reusable applications?
The device is not inherently single-use or reusable—its application depends on the manufacturer’s guidelines, which must be followed to ensure proper use and safety. The tester itself is battery-operated and rechargeable, but the accessories may vary in their intended use.
What types of electrosurgical instruments can be tested with this device, and how is it supplied?
The tester is supplied with accessories specifically designed to test various electrosurgical instruments, allowing for compatibility with a range of devices. The exact instruments supported depend on the included adapters, which are part of the supplied package for Models ATI014 & ATI014 FC.
Is this device compatible with MRI environments, and what regulatory pathway was followed for its clearance?
No, the Insulation and Continuity Tester Plus is not intended for MRI use. It was cleared through the FDA’s 510(k) pathway (K020334) under the Traditional review process, with a decision of Substantially Equivalent (SESE) in the Electrosurgical, Cutting & Coagulation & Accessories category (Product Code GEI).