3.5 MM LAPAROSCOPE (LG100, LG103)— 510(k) K001594

Substantially Equivalent

Surgical Image Laboratories, Inc.

FDA 510(k) clearance K001594 for 3.5 MM LAPAROSCOPE (LG100, LG103), Substantially Equivalent on 2000-06-12. Applicant: Surgical Image Laboratories, Inc..

Clearance details

Applicant: Surgical Image Laboratories, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2000-05-23
Decision date: 2000-06-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Deerfield Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.