VenoTrain soft 21264811500331

by Bauerfeind GmbH & Co.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 9 Nov 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04046445525971 UDI-DI	Date6 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK860826	Date18 Jun 1986Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04046445525971
FDA 510(k) database 510(k) number K860826

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 Nov 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: VenoTrain soft
Generic name: Compression/pressure sock/stocking, single-use
Model / reference: 21264811500331

Primary DI / UDI-DI: 04046445525971
510(k) Number: K860826
FDA product code: DWL
GMDN term: Compression/pressure sock/stocking, single-use

Device class: Class II
Regulation number: 880.5780
GUDID distribution status: In Commercial Distribution

Other devices from Bauerfeind GmbH & Co.

VenoTrain micro 21860624500334

Class II
VenoTrain look 21760621700322

Class II
VenoTrain soft 21260010020333

Class II
VenoTrain micro 21810014820323

Class II
VenoTrain micro 28560315100334

Class II
VenoTrain soft 21264714800224

Class II

See all devices from Bauerfeind GmbH & Co. →

Properties

Single use
Over-the-counter
Lot / batch number
Expiration date

Other properties (11)

Supplied sterile: No
Sterilise before use: No
Implantable: No
Contains latex: No
Prescription use: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No