K141127 is an FDA 510(k) clearance for the MEDLINE ANTI-EMBOLISM STOCKING. This device is classified as a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II - Special Controls, product code DWL).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on August 21, 2014, 112 days after receiving the submission on May 1, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5780.
| 510(k) Number | K141127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2014 |
| Decision Date | August 21, 2014 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | DWL — Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5780 |