Skip to content

Vygon Mbs-2010

by Vygon Corp. 2 variants

Vygon Mbs-2010 is a Class II device made by Vygon Corp., cleared under FDA 510(k) K873957 on 23 Oct 1987 and listed in FDA GUDID since 25 Mar 2020 (UDI-DI 00849884001624), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K873957

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00849884001624 UDI-DI Date25 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK873957 Date23 Oct 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K873957 decided 23 Oct 1987 Active
  • FDA GUDID UDI-DI 00849884001624 listed 25 Mar 2020 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0681-2018 FDA Class II initiated 24 Jul 2017

    Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.

    • Terminated Z-1480-2012 FDA Not yet classified initiated 16 Apr 2012

    Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device label.

Timeline

4 dated events

  1. Cleared FDA 510(k) K873957
  2. Recall initiated FDA recalls Z-1480-2012
  3. Recall initiated FDA recalls Z-0681-2018
  4. Listed FDA GUDID 00849884001624

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vygon
Generic name
Vascular port administration set
Model / Ref / Catalog
MBS-2010
Primary DI / UDI-DI
00849884001624
510(k) Number
FDA product code
FMI
GMDN term
Vascular port administration set
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vascular port administration set

Cleared under the same submission (K873957)

and 8 more cleared under K873957

Similar devices

Other devices filed under FDA product code FMI (Needle, hypodermic, single lumen).

Other devices from Vygon Corp.

See all devices from Vygon Corp. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)