ILS(TM) - INVASIVE LINE SEPARATOR— 510(k) K924369

Substantially Equivalent

2-Rn Corp.

FDA 510(k) clearance K924369 for ILS(TM) - INVASIVE LINE SEPARATOR, Substantially Equivalent on 1993-02-05. Applicant: 2-Rn Corp..

Clearance details

Applicant: 2-Rn Corp.
Product code: Code KMK
Advisory panel: General Hospital
Date received: 1992-08-28
Decision date: 1993-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.