Jac-Cell Medic testers
by Jac-Cell Medic 510(k)
Active
510(k) K170105
Overview
The Jac-Cell Medic ATI-014AFC is an insulation and continuity tester (Device Type: GEI – Electrical Testing Instruments). It is designed to verify the integrity of electrical insulation on laparoscopic instruments, including handles, tubes, monopolar and bipolar bayonets, and vaginal speculums. This device ensures patient safety by confirming that insulated components remain non-conductive and functional before use in surgical procedures. Its fourth-generation design incorporates advanced testing capabilities to meet clinical standards for plastic and reconstructive surgery instruments.
The ATI-014AFC is a portable, battery-powered device with a foot control switch, enabling hands-free operation during testing. It is supplied as a standalone tester and is intended for single-use or reusable applications in sterile or semi-sterile settings, such as operating rooms or surgical centers. The device adheres to FDA 510(k) clearance (K170105) under the General, Plastic Surgery advisory committee and is classified under product code GEI. No specific MRI safety or sterility certification beyond regulatory compliance is stated in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170105 | Date28 Feb 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Jac-Cell Medic Corporation
Questions
What is the Jac-Cell Medic ATI-014AFC used for?
The ATI-014AFC is designed specifically to test the insulation integrity of laparoscopic instruments, such as handles, tubes, monopolar/bipolar bayonets, and vaginal speculums. It ensures these components remain non-conductive and functional, directly supporting patient safety during plastic and reconstructive surgery procedures by confirming electrical safety before use.
How is the ATI-014AFC supplied and intended for use?
The device is supplied as a standalone, portable tester and is intended for use in sterile or semi-sterile environments like operating rooms or surgical centers. It operates on battery power and includes a foot control switch for hands-free operation, making it convenient for clinical settings where sterility and efficiency are critical.
Is the ATI-014AFC single-use or reusable?
The ATI-014AFC is designed for both single-use and reusable applications, depending on clinical protocols and facility preferences. Its portability and battery operation make it adaptable to various sterile or semi-sterile workflows, though users must follow manufacturer guidelines for cleaning, disinfection, or disposal to maintain performance and safety.
Does the ATI-014AFC require any special storage conditions?
The device does not specify unique storage requirements beyond standard environmental conditions for electrical testing instruments. It should be stored in a clean, dry place away from direct sunlight, extreme temperatures, or moisture to preserve battery life and operational integrity. If reusable, follow facility protocols for maintenance between uses.
What regulatory pathway does the ATI-014AFC follow?
The ATI-014AFC holds FDA 510(k) clearance (K170105) under the General, Plastic Surgery advisory committee, classified under product code GEI (Electrical Testing Instruments). This clearance confirms it meets U.S. regulatory standards for electrical insulation testing devices, ensuring compliance with safety requirements for laparoscopic instruments in surgical settings.