DiLumen Endolumenal Interventional Knife (DiLumen IK)— 510(k) K183112

Name: FDA 510(k) clearance K183112
Creator: U.S. Food and Drug Administration
Published: 2019-08-02

Substantially Equivalent

Lumendi, LLC

FDA 510(k) clearance K183112 for DiLumen Endolumenal Interventional Knife (DiLumen IK), Substantially Equivalent on 2019-08-02. Applicant: Lumendi, LLC. Device class: 2.

Clearance details

Applicant: Lumendi, LLC
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2018-11-08
Decision date: 2019-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westport, CT, US

Download summary PDF View on FDA.gov ↗

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K173405 — DiLumen Endolumenal Interventional Scissors (DiLumen Is)2018-05-22

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.