AMSURE CLEANSING ENEMA SET— 510(k) K974042

Name: FDA 510(k) clearance K974042
Creator: U.S. Food and Drug Administration
Published: 1997-12-19

Substantially Equivalent

Amsino Intl., Inc.

FDA 510(k) clearance K974042 for AMSURE CLEANSING ENEMA SET, Substantially Equivalent on 1997-12-19. Applicant: Amsino Intl., Inc.. Device class: 1.

Clearance details

Applicant: Amsino Intl., Inc.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1997-10-24
Decision date: 1997-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amsino Intl., Inc.

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K973107 — AMSINO I.V. ADMINISTRATION SET1997-10-02
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K971929 — AMSINO URINARY LEG BAG1997-08-06

Adverse events under product code FCE

product code FCE

Other: 2
Total: 2

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.