Sterile Disposable Syringes(2 Pieces)

by Fabersanitas, S.A. 510(k)

Active United States

510(k) K852818

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK852818	Date29 Jul 1985Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K852818
FDA Product Code: FMF

Device Class: Class II
Regulation: 21 CFR Part 880.5860
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

Other devices from Fabersanitas, S.A.

Sterile, Disposable Needle

Class I
Sterile Disposable Syringe(3 Pieces)

Class II