Medline Anti-Embolism Stocking
FDA 510(k) K141127 · Medline Industries, Inc.
510(k) numberK141127
Submission
- Device name
- Medline Anti-Embolism Stocking
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- May 1, 2014
- Decision date
- August 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DWL – Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5780
- Specialty
- General Hospital
Other 510(k)s with product code DWL
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|---|---|---|---|
| K131496 | Bellavar / Custom Seamless Soft (A.K.A. Comtesse)DWL · Special | Bsn Medical, Inc. | 07/10/2013SE |
| K122485 | Encircle Compression Therapy StockingDWL · Traditional | Encircle Medical Devices , Ltd. | 04/23/2013SE |
| K123820 | Bossong Hosiery Medical Compression Stockings 8-15 MMHG, Bossong Hosiery Anti-Embolism…DWL · Traditional | Bossong Hosiery Mills, Inc. | 04/02/2013SE |
| K123085 | Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings…DWL · Traditional | 3M Company | 12/20/2012SE |
| K123561 | Elvarex/Elvarex Soft/Elvarex Soft SeamlessDWL · Special | Bsn Medical, Inc. | 12/18/2012SE |
| K123398 | Dr. Scholl's Compression SocksDWL · Traditional | Renfro Corporation | 12/18/2012SE |
| K121106 | Truform Ready-To-Wear Compression Arm Sleece Truform Ready-To-Wear Compression GauntletDWL · Traditional | Surgical Appliance Industries, Inc. | 04/27/2012SE |
| K112769 | Curad Compression HosieryDWL · Traditional | Medline Industries, Inc. | 03/01/2012SE |
| K111662 | Venotrain CuraflowDWL · Traditional | Bauerfeind AG | 10/04/2011SE |
| K101614 | Heelsafe DVT Hose, Models 00800-00804, 00805-00809DWL · Traditional | Dm Systems, Incorporated | 01/13/2011SE |
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Questions and answers
When was Medline Anti-Embolism Stocking cleared by the FDA?
Medline Anti-Embolism Stocking (K141127) received a 510(k) decision of Substantially Equivalent on August 21, 2014, 112 days after the submission was received.
What is the product code of K141127?
The FDA product code is DWL – Stocking, Medical Support (To Prevent Pooling Of Blood In Legs), a Class II (moderate risk) device regulated under 21 CFR 880.5780.