K873466 is an FDA 510(k) clearance for the EXCEL PULSED IRRIGATION/SUCTION SYSTEM. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on November 6, 1987, 70 days after receiving the submission on August 28, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K873466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1987 |
| Decision Date | November 06, 1987 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |