K922083 is an FDA 510(k) clearance for the RMI SURGICCAL SITE VISUALIZATION WAND. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on January 29, 1993, 270 days after receiving the submission on May 4, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K922083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1992 |
| Decision Date | January 29, 1993 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |