LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS— 510(k) K955845

Substantially Equivalent

Surgical Image Laboratories, Inc.

FDA 510(k) clearance K955845 for LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS, Substantially Equivalent on 1996-07-05. Applicant: Surgical Image Laboratories, Inc..

Clearance details

Applicant: Surgical Image Laboratories, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1995-12-22
Decision date: 1996-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
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.