EXTERNAL MALE CATHETER— 510(k) K852051

Name: FDA 510(k) clearance K852051
Creator: U.S. Food and Drug Administration
Published: 1985-08-22

Substantially Equivalent

Buffalo Medical Specialties Mfg., Inc.

FDA 510(k) clearance K852051 for EXTERNAL MALE CATHETER, Substantially Equivalent on 1985-08-22. Applicant: Buffalo Medical Specialties Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Buffalo Medical Specialties Mfg., Inc.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-09
Decision date: 1985-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNX

view all

K110518 — IBAG2011-06-24
K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG1998-03-17
K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG1997-12-11
K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM1997-08-18
K971929 — AMSINO URINARY LEG BAG1997-08-06

More clearances from Buffalo Medical Specialties Mfg., Inc.

view all

K902132 — CUFF, BLOOD PRESSURE1990-06-29
K830569 — CYNOX I HEMOGLOBINOMETER1983-04-08

Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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.