K202071 is an FDA 510(k) clearance for the SURGIPHOR Wound Irrigation System. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Orthophor, LLC (Philadelphia, US). The FDA issued a Cleared decision on October 23, 2020, 88 days after receiving the submission on July 27, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K202071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2020 |
| Decision Date | October 23, 2020 |
| Days to Decision | 88 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 |