URIDROP— 510(k) K791196

Name: FDA 510(k) clearance K791196
Creator: U.S. Food and Drug Administration
Published: 1979-07-30

Substantially Equivalent

Ab Medett Produkter

FDA 510(k) clearance K791196 for URIDROP, Substantially Equivalent on 1979-07-30. Applicant: Ab Medett Produkter. Device class: 2.

Clearance details

Applicant: Ab Medett Produkter
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1979-06-26
Decision date: 1979-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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 Ab Medett Produkter

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K791197 — URIDROP SPECIAL1979-07-30
K791198 — BIBAG1979-07-30

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.