ELRAN 01 SYSTEM
by Envision Advanced Medical System, Ltd. 510(k)
Active
510(k) K002431
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002431 | Date24 Oct 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The ELRAN 01 SYSTEM is a laparoscope for general and plastic surgery, as indicated by its classification name and medical specialty in gastroenterology and urology. It is a medical device cleared under FDA 510(k) K002431 as substantially equivalent to a predicate device.
The device was cleared by the FDA on October 24, 2000, following an abbreviated review process. It is manufactured by Envision Advanced Medical System, Ltd., and is identified by product code GCJ. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or clinical indications is provided in the data.
Questions
AI-generated answers, 19 Sep 2026
What types of surgical procedures is the ELRAN 01 SYSTEM primarily designed for based on its regulatory classification?
The ELRAN 01 SYSTEM is classified under the FDA’s product code GCJ, which falls within the Gastroenterology and Urology advisory committees. This classification indicates it is intended for general laparoscopic procedures in these specialties, including surgeries where visual access to internal organs or cavities is required. The device’s clearance as substantially equivalent to a predicate device further supports its use in minimally invasive surgeries within these fields.
How was the ELRAN 01 SYSTEM’s FDA clearance process conducted, and what does that mean for its regulatory status?
The ELRAN 01 SYSTEM was cleared through an abbreviated review process (510(k) K002431) by the FDA on October 24, 2000. This means the manufacturer demonstrated that their device was substantially equivalent to a legally marketed predicate device, allowing it to bypass full clinical trials. The clearance does not imply new indications but confirms compliance with existing regulatory standards for laparoscopic devices in the specified categories.
Is the ELRAN 01 SYSTEM intended for single-use or reusable applications, and what should I consider when handling it?
The provided data does not specify whether the ELRAN 01 SYSTEM is designed for single-use or reuse. If reusable, it would require strict cleaning, sterilization, and maintenance protocols to prevent contamination or damage. If single-use, proper disposal procedures must be followed. Always refer to the manufacturer’s instructions or local infection control guidelines for handling, as these details are critical for safe use.
What should I know about storing the ELRAN 01 SYSTEM to maintain its performance and sterility?
The data does not provide explicit storage instructions for the ELRAN 01 SYSTEM, such as temperature ranges or environmental conditions. If the device is sterile, it should be stored in a sealed, protected environment to prevent contamination. If reusable, storage should comply with manufacturer guidelines to avoid physical damage or degradation. For optimal use, consult the accompanying documentation or contact Envision Advanced Medical Systems for manufacturer-recommended storage practices.