K974042 is an FDA 510(k) clearance for the AMSURE CLEANSING ENEMA SET, a Enema Kit (Class I — General Controls, product code FCE), submitted by Amsino Intl., Inc. (Pomona, US). The FDA issued a Cleared decision on December 19, 1997, 56 days after receiving the submission on October 24, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5210.
| 510(k) Number | K974042 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 24, 1997 |
| Decision Date | December 19, 1997 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCE — Enema Kit |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.5210 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.this Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance. |