URINARY DRAINAGE UNT— 510(k) K802664

Name: FDA 510(k) clearance K802664
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

Diamed Division Ill. Tool Works, Inc.

FDA 510(k) clearance K802664 for URINARY DRAINAGE UNT, Substantially Equivalent on 1980-11-12. Applicant: Diamed Division Ill. Tool Works, Inc.. Device class: 2.

Clearance details

Applicant: Diamed Division Ill. Tool Works, Inc.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1980-10-28
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code KNX

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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 Diamed Division Ill. Tool Works, Inc.

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K854953 — DIAMED MODELS 600, 900, 960, 9641986-04-22
K823450 — FEMALE EXTERNAL URINARY APPLIANCE1982-12-28
K812281 — TOUCHLESS HOME-CATH1981-10-13
K802665 — TOUCHLESS CLEAN-CATH1980-11-12
K790728 — TOUCHLESS TM FOLEY CATHETER KIT1979-06-01

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.