K231023 is an FDA 510(k) clearance for the ERBEJET® 2 System. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Erbe Elektromedizin GmbH (Tuebingen, DE). The FDA issued a Cleared decision on June 15, 2023, 65 days after receiving the submission on April 11, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K231023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2023 |
| Decision Date | June 15, 2023 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FQH - Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |