LARGE VOLUME ENEMA CONTAINER DISPOSABLE— 510(k) K800959

Name: FDA 510(k) clearance K800959
Creator: U.S. Food and Drug Administration
Published: 1980-05-14

Substantially Equivalent

The Healthcare Group Laboratories, Inc.

FDA 510(k) clearance K800959 for LARGE VOLUME ENEMA CONTAINER DISPOSABLE, Substantially Equivalent on 1980-05-14. Applicant: The Healthcare Group Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: The Healthcare Group Laboratories, Inc.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1980-04-23
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K931896 — PRO-FLO SYSTEM1993-08-26
K922398 — 4 SURE TM ENEMA BAG SET1993-06-17
K913620 — ENEMA KIT1991-11-01
K904534 — ENEMA BULB1990-12-21

More clearances from The Healthcare Group Laboratories, Inc.

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K850035 — EMPTY SOLUTION TRANSFER CONTAINER1985-06-07
K842170 — EMPTY SOLUTION TRANSFER CONTAINER1984-10-19
K842091 — DISPOS. ACU-CUT SOFT TISSUE BIOPSY1984-07-23
K840742 — RIGHT ATRIAL CATHETER1984-07-13
K830299 — SOLUTION TRANSFER CONTAINER1983-02-19

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.