ENEMA BULB— 510(k) K904534

Name: FDA 510(k) clearance K904534
Creator: U.S. Food and Drug Administration
Published: 1990-12-21

Substantially Equivalent

R.A.C., Inc.

FDA 510(k) clearance K904534 for ENEMA BULB, Substantially Equivalent on 1990-12-21. Applicant: R.A.C., Inc.. Device class: 1.

Clearance details

Applicant: R.A.C., Inc.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1990-10-04
Decision date: 1990-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FCE

view all

K974042 — AMSURE CLEANSING ENEMA SET1997-12-19
K931896 — PRO-FLO SYSTEM1993-08-26
K922398 — 4 SURE TM ENEMA BAG SET1993-06-17
K913620 — ENEMA KIT1991-11-01
K901179 — ENEMA BUCKET SET1990-06-28

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.