K011612 is an FDA 510(k) clearance for the MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Hydrocision, Inc. (Hopkonton, US). The FDA issued a Cleared decision on June 22, 2001, 28 days after receiving the submission on May 25, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K011612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2001 |
| Decision Date | June 22, 2001 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |