URINE BAG SYSTEM— 510(k) K831796

Name: FDA 510(k) clearance K831796
Creator: U.S. Food and Drug Administration
Published: 1983-08-08

Substantially Equivalent

I M, Inc.

FDA 510(k) clearance K831796 for URINE BAG SYSTEM, Substantially Equivalent on 1983-08-08. Applicant: I M, Inc.. Device class: 2.

Clearance details

Applicant: I M, Inc.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1983-06-03
Decision date: 1983-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 I M, Inc.

view all

K914600 — NEUROLOGICAL SPONGE1992-12-30
K892389 — BIOPSY KIT1989-07-17
K881363 — SYRINGE PREFILLED WITH WATER1988-06-23
K880753 — UMBILICAL CORD CLAMP1988-04-27
K872741 — NUTRIPUMP1987-10-20

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.