KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.— 510(k) K921054

Name: FDA 510(k) clearance K921054
Creator: U.S. Food and Drug Administration
Published: 1992-09-23

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K921054 for KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH., Substantially Equivalent on 1992-09-23. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: 2.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1992-03-05
Decision date: 1992-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04

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.