S-41 & S-41S Video Imaging System
by Del Medical Systems Corp. 510(k)
Active
510(k) K962020
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962020 | Date30 Aug 1996 | 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- Withdrawn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, 1 Oct 2026
The S-41 and S-41S Video Imaging System is a video imaging device designed for use in medical procedures, specifically within the categories of laparoscopy (General & Plastic Surgery). It captures visual data via an integrated camera, processes the signals, and provides real-time video output for display, facilitating visual feedback during clinical interventions.
This system is intended for use in clinical settings by practitioners in gastroenterology and urology. It is a reusable device, supplied as a complete imaging solution with no indication of sterility requirements. The system adheres to FDA regulatory standards, having received FDA 510(k) clearance (K962020) under the Substantially Equivalent (SESE) designation, with a classification under product code GCJ. No specific MRI safety or storage conditions are noted in the available data.
Other devices from Del Medical Systems Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the S-41 & S-41S Video Imaging System used for?
The S-41 & S-41S Video Imaging System is specifically designed for laparoscopic procedures in general and plastic surgery. It captures visual data via an integrated camera, processes the signals, and provides real-time video output to assist practitioners in visualizing internal anatomy during interventions. This is particularly useful in minimally invasive surgeries where precise visualization is critical.
Is the S-41 & S-41S Video Imaging System reusable or single-use?
The S-41 & S-41S Video Imaging System is a reusable device. It is supplied as a complete imaging solution, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. There are no sterility requirements specified for this system, as it is not intended for single-use applications.
Which medical specialties can use the S-41 & S-41S Video Imaging System?
This system is intended for use by practitioners in gastroenterology and urology, as well as general and plastic surgeons performing laparoscopic procedures. The FDA clearance under the Gastroenterology and Urology advisory committees reflects its primary intended clinical applications.
What regulatory clearance does the S-41 & S-41S Video Imaging System hold?
The S-41 & S-41S Video Imaging System has received FDA 510(k) clearance under the Substantially Equivalent (SESE) designation with clearance number K962020. This classification under product code GCJ indicates it is considered substantially equivalent to a legally marketed device in its category.
Are there any special storage or handling instructions for the S-41 & S-41S Video Imaging System?
The available data does not specify any special MRI safety or storage conditions for the S-41 & S-41S Video Imaging System. However, as a reusable device, it should be stored in a clean, dry environment and maintained according to manufacturer guidelines to ensure proper functionality and longevity.