K926225 is an FDA 510(k) clearance for the SPONGE COUNTER, a Operating Room Accessories Table Tray (Class I — General Controls, product code FWZ), submitted by American Medical Manufacturer, Inc. (Canoga Park, US). The FDA issued a Cleared decision on March 5, 1993, 85 days after receiving the submission on December 10, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K926225 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 10, 1992 |
| Decision Date | March 05, 1993 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FWZ — Operating Room Accessories Table Tray |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4950 |
| 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. |