K901182 is an FDA 510(k) clearance for the ENEMA BAG SET. This device is classified as a Enema Kit (Class I - General Controls, product code FCE).
Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on June 28, 1990, 107 days after receiving the submission on March 13, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5210. 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..
| 510(k) Number | K901182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | March 13, 1990 |
| Decision Date | June 28, 1990 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| 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. |