K123561 is an FDA 510(k) clearance for the ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS. 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 Bsn Medical, Inc. (Rutherford College, US). The FDA issued a Cleared decision on December 18, 2012, 29 days after receiving the submission on November 19, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5780.
| 510(k) Number | K123561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2012 |
| Decision Date | December 18, 2012 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |