K033590 is an FDA 510(k) clearance for the ERBE HELIX HYDRO-JET. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on January 30, 2004, 81 days after receiving the submission on November 10, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K033590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2003 |
| Decision Date | January 30, 2004 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |