CATHETER, AKRON FOLEY TEFLON— 510(k) K781751

Name: FDA 510(k) clearance K781751
Creator: U.S. Food and Drug Administration
Published: 1979-01-22

Substantially Equivalent

Latex Ind., Inc.

FDA 510(k) clearance K781751 for CATHETER, AKRON FOLEY TEFLON, Substantially Equivalent on 1979-01-22. Applicant: Latex Ind., Inc.. Device class: 2.

Clearance details

Applicant: Latex Ind., Inc.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1978-10-16
Decision date: 1979-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K812058 — AKRON URINARY DRAINAGE BAT1981-07-31
K810281 — UROLOGICAL CATHETERS1981-02-25
K791674 — BLADDER RETENTION CATHETERIZATION TRAY1979-11-05
K781433 — AKRON MALE EXTERNAL CATHETER1978-11-03
K772277 — BLADDER RETENTION-CATHETHERIZATIONTRAY1978-03-02

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.