CATHETER INSERTION TRAY— 510(k) K802083

Name: FDA 510(k) clearance K802083
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

Walpak Co.

FDA 510(k) clearance K802083 for CATHETER INSERTION TRAY, Substantially Equivalent on 1980-09-16. Applicant: Walpak Co.. Device class: 2.

Clearance details

Applicant: Walpak Co.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1980-08-29
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K803198 — IRRIGATION SET W/PISTON SYRINGE1981-01-15
K803199 — SUTURE REMOVAL KIT1981-01-15
K803201 — LEMON GLYCERINE SWABS1980-12-17

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.