14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH— 510(k) K013162

Name: FDA 510(k) clearance K013162
Creator: U.S. Food and Drug Administration
Published: 2001-10-19

Substantially Equivalent

Medcomp

FDA 510(k) clearance K013162 for 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH, Substantially Equivalent on 2001-10-19. Applicant: Medcomp. Device class: 2.

Clearance details

Applicant: Medcomp
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2001-09-21
Decision date: 2001-10-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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K091954 — MICRO-STICK SET2010-01-08
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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.