INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM— 510(k) K042069

Name: FDA 510(k) clearance K042069
Creator: U.S. Food and Drug Administration
Published: 2004-11-01

Substantially Equivalent

Acmi Corporation

FDA 510(k) clearance K042069 for INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM, Substantially Equivalent on 2004-11-01. Applicant: Acmi Corporation. Device class: 2.

Clearance details

Applicant: Acmi Corporation
Product code: Code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2004-08-02
Decision date: 2004-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

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K060269 — ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM2006-03-31
K051593 — UROPASS URETERAL ACCESS SHEATH, MODEL 612242005-09-02
K052044 — ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL2005-08-16

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.