ENEMA KIT— 510(k) K761167

Name: FDA 510(k) clearance K761167
Creator: U.S. Food and Drug Administration
Published: 1976-12-09

Substantially Equivalent

American Hospital Supply Corp.

FDA 510(k) clearance K761167 for ENEMA KIT, Substantially Equivalent on 1976-12-09. Applicant: American Hospital Supply Corp.. Device class: 1.

Clearance details

Applicant: American Hospital Supply Corp.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1976-12-01
Decision date: 1976-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K922398 — 4 SURE TM ENEMA BAG SET1993-06-17
K913620 — ENEMA KIT1991-11-01
K904534 — ENEMA BULB1990-12-21

More clearances from American Hospital Supply Corp.

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K854739 — AMERICAN STERILE SURGICAL ABSORBENT TOWEL1985-12-27
K854759 — AMERICAN STERILE MAYO STAND TRAY1985-12-17
K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS1984-04-23
K830546 — DOSIMETRIC RELEASE1983-05-25
K822990 — CONVERTORS PRIMARY WOUND DRESSING II1983-04-12

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.