NELATON-, FEMALE - OR TIEMANN CATHETER— 510(k) K896729

Name: FDA 510(k) clearance K896729
Creator: U.S. Food and Drug Administration
Published: 1990-11-05

Substantially Equivalent

Unoplast A/S

FDA 510(k) clearance K896729 for NELATON-, FEMALE - OR TIEMANN CATHETER, Substantially Equivalent on 1990-11-05. Applicant: Unoplast A/S. Device class: 2.

Clearance details

Applicant: Unoplast A/S
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-30
Decision date: 1990-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOD

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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 Unoplast A/S

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K896734 — FEEDING TUBE1990-12-21
K896732 — UNOMETER 5001990-11-02
K896730 — SUCTION CATHETER STRAIGHT/COUDE1990-03-30
K896731 — OXYGEN CATHETERS1990-03-30
K896733 — VACCON1990-02-01

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 →

Recalls naming K896729

K-number listed on FDA's recall record

Z-1037-2019 — Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).Class II·Ongoing·ConvaTec, Inc·20190109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K896729.

Data sourced from openFDA. This site is unofficial and independent of the FDA.