ENEMA BAG SET— 510(k) K901182

Name: FDA 510(k) clearance K901182
Creator: U.S. Food and Drug Administration
Published: 1990-06-28

Unknown

Orion Life Systems, Inc.

FDA 510(k) clearance K901182 for ENEMA BAG SET, Unknown on 1990-06-28. Applicant: Orion Life Systems, Inc.. Device class: 1.

Clearance details

Applicant: Orion Life Systems, Inc.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-13
Decision date: 1990-06-28
Decision: Unknown
Clearance type: Traditional
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Orion Life Systems, Inc.

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K943835 — PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID1995-01-24
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K943829 — PRE-FILLED SYSRINGE W/STERILE WATER1994-11-21
K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION1994-11-21
K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER1994-11-21

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.