C-Cord
by Concept, Inc. 510(k)
Active
510(k) K782046
Overview
The C-Cord is an Electric Cord, For Endoscope (Device Class II, FDA Product Code FFZ), designed as a flexible, insulated electrical cable for connecting endoscopic equipment to power sources. It facilitates the safe transmission of electrical current during gastrointestinal and urological endoscopic procedures, ensuring reliable operation of endoscopes and associated devices. Constructed to meet stringent medical-grade standards, it is engineered to withstand repeated use in clinical settings while maintaining electrical integrity.
Supplied as a reusable device, the C-Cord is intended for use in sterile or semi-sterile environments, such as operating rooms, endoscopy suites, and urology clinics. It must be cleaned and inspected according to manufacturer guidelines to prevent contamination and ensure functionality. The device adheres to FDA clearance under 510(k) K782046, with regulatory oversight under 21 CFR 876.1500, and is classified under the Gastroenterology and Urology medical specialties. Storage should follow facility protocols to avoid damage to the cable’s insulation and connectors.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK782046 | Date10 Jan 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FFZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Concept, Inc.
Questions
What is the C-Cord used for in clinical settings?
The C-Cord is designed as a flexible, insulated electrical cable to connect endoscopic equipment to power sources during gastrointestinal and urological endoscopic procedures. It ensures reliable electrical transmission for endoscopes and associated devices, maintaining safe and uninterrupted operation in sterile or semi-sterile environments like operating rooms, endoscopy suites, and urology clinics.
Is the C-Cord a single-use or reusable device?
The C-Cord is supplied as a reusable device. To ensure safety and functionality, it must be cleaned and inspected according to the manufacturer’s guidelines after each use. Proper maintenance prevents contamination and preserves the cable’s electrical integrity for repeated clinical applications.
What storage guidelines should be followed for the C-Cord?
The C-Cord should be stored following facility protocols to avoid damage to its insulation and connectors. Proper storage conditions help maintain the cable’s performance and longevity, ensuring it remains reliable for use in endoscopic procedures.
Does the C-Cord require sterilization before use?
The C-Cord is intended for use in sterile or semi-sterile environments, but it is not a sterile device by default. It must be cleaned and inspected thoroughly after each use to meet clinical hygiene standards before reuse. Sterilization is not applicable; instead, adherence to cleaning protocols ensures safe and functional performance.
What regulatory approval does the C-Cord hold?
The C-Cord holds FDA clearance under 510(k) number K782046, classified as substantially equivalent to a predicate device. It is regulated under 21 CFR 876.1500 and is intended for use in gastroenterology and urology procedures, adhering to medical-grade safety and performance standards.