Submission Details
| 510(k) Number | K123085 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 01, 2012 |
| Decision Date | December 20, 2012 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
K123085 - FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE
(FDA 510(k) Clearance)
Dec 2012
Decision
80d
Days
Class 2
Risk
K123085 is an FDA 510(k) clearance for the FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE, a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II — Special Controls, product code DWL), submitted by 3M Company (Saint Paul, US). The FDA issued a Cleared decision on December 20, 2012, 80 days after receiving the submission on October 1, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5780.
Device Classification
| 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 |
Similar Devices — DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
All 63
K141127 · Medline Industries, Inc.
· Aug 2014
K131496 · Bsn Medical, Inc.
· Jul 2013
K122485 · Encircle Medical Devices , Ltd.
· Apr 2013
K123820 · Bossong Hosiery Mills, Inc.
· Apr 2013
K123398 · Renfro Corporation
· Dec 2012
K123561 · Bsn Medical, Inc.
· Dec 2012