PEDIATRIC URINE COLLECTOR— 510(k) K823411

Name: FDA 510(k) clearance K823411
Creator: U.S. Food and Drug Administration
Published: 1982-12-28

Substantially Equivalent

Sage Products, Inc.

FDA 510(k) clearance K823411 for PEDIATRIC URINE COLLECTOR, Substantially Equivalent on 1982-12-28. Applicant: Sage Products, Inc.. Device class: 2.

Clearance details

Applicant: Sage Products, Inc.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1982-11-15
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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More clearances from Sage Products, Inc.

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K973911 — 2 GALLON ALTERNATE CARE SHARPS CONTAINER1997-10-29
K972279 — SHARPS SHUTTLE1997-08-29
K970135 — NITRILE GLOVES1997-08-25

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.