CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT— 510(k) K032710

Name: FDA 510(k) clearance K032710
Creator: U.S. Food and Drug Administration
Published: 2004-01-09

Substantially Equivalent

Apogee Medical, Inc.

FDA 510(k) clearance K032710 for CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT, Substantially Equivalent on 2004-01-09. Applicant: Apogee Medical, Inc.. Device class: 2.

Clearance details

Applicant: Apogee Medical, Inc.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-02
Decision date: 2004-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Youngsville, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOD

view all

K251864 — Rubber Utility Catheter2026-02-23
K220036 — Wellead Ureteral Catheter2022-12-16
K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters2022-10-13
K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr2021-11-19
K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter2019-05-24

More clearances from Apogee Medical, Inc.

view all

K011552 — UROLOGICAL CATHETER2001-07-18

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.