K991383 is an FDA 510(k) clearance for the HYDROCISION DEBDRIDEMENT 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 March 31, 2000, 345 days after receiving the submission on April 21, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K991383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1999 |
| Decision Date | March 31, 2000 |
| Days to Decision | 345 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 |