S-52 Electronic Video Laparoscope
by Del Medical Systems Corp. 510(k)
Active
510(k) K962651
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962651 | Date30 Sep 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- Withdrawn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, 26 Sep 2026
The S-52 Electronic Video Laparoscope is an endoscopic imaging device designed to assist in the observation and recording of surgical procedures. It functions by capturing visual data from the surgical site within body cavities, hollow organs, and canals.
This device is intended for use in laparoscopic procedures. It has received FDA 510(k) clearance under the reference number K962651.
Other devices from Del Medical Systems Corp.
Questions
AI-generated answers, 26 Sep 2026
What is the primary function of the S-52 Electronic Video Laparoscope?
The S-52 is an endoscopic imaging device designed to assist surgeons by capturing visual data from surgical sites. It is specifically intended for use during laparoscopic procedures to observe and record activity within body cavities, hollow organs, and canals.
What is the regulatory status of this device?
The S-52 Electronic Video Laparoscope has received FDA 510(k) clearance under reference number K962651. This indicates that the device was reviewed and determined to be substantially equivalent to legally marketed predicate devices.
Which medical specialties is this device associated with?
The device is associated with the Gastroenterology and Urology advisory committees. These committees oversee the review process for medical equipment intended for use in these specific clinical fields.