K936223 is an FDA 510(k) clearance for the PRESSURE IRRIGATING SYSTEM, a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I — General Controls, product code GCY), submitted by Level 1 Technologies, Inc. (Rockland, US). The FDA issued a Cleared decision on May 12, 1994, 134 days after receiving the submission on December 29, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4680.
| 510(k) Number | K936223 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 1993 |
| Decision Date | May 12, 1994 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4680 |