K152538 is an FDA 510(k) clearance for the JRP Wound Spreader. This device is classified as a Retractor (Class I — General Controls, product code GAD).
Submitted by J.R. Parker, LLC (West Chester, US). The FDA issued a Cleared decision on April 13, 2016, 222 days after receiving the submission on September 4, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K152538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2015 |
| Decision Date | April 13, 2016 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAD — Retractor |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |