K022613 is an FDA 510(k) clearance for the 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 October 25, 2002, 80 days after receiving the submission on August 6, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K022613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2002 |
| Decision Date | October 25, 2002 |
| Days to Decision | 80 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 |