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Vygon VYCIS007

by Vygon Corp.

Vygon VYCIS007 is a Class II device made by Vygon Corp., cleared under FDA 510(k) K011336 on 12 Jun 2001 and listed in FDA GUDID since 28 Jul 2017 (UDI-DI 08498840010907), active as of 23 Oct 2026. 9 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

9 closed

Documents

510(k) K011336

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 Number08498840010907 UDI-DI Date28 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011336 Date12 Jun 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011336 decided 12 Jun 2001 Active
  • FDA GUDID UDI-DI 08498840010907 listed 28 Jul 2017 Listed

Recalls

9 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-1332-2011 FDA Unclassified (pre-2012) initiated 16 Nov 2010
    • Terminated Z-1322-2011 FDA Unclassified (pre-2012) initiated 16 Nov 2010
    • Terminated Z-1324-2011 FDA Unclassified (pre-2012) initiated 16 Nov 2010
    • Terminated Z-1321-2011 FDA Unclassified (pre-2012) initiated 16 Nov 2010
    • Terminated Z-1320-2011 FDA Unclassified (pre-2012) initiated 16 Nov 2010
    • Terminated Z-1328-2011 FDA Unclassified (pre-2012) initiated 16 Nov 2010
    • Terminated Z-1319-2011 FDA Unclassified (pre-2012) initiated 16 Nov 2010
    • Terminated Z-1329-2011 FDA Unclassified (pre-2012) initiated 16 Nov 2010

    Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

    • Terminated Z-1639-2010 FDA Unclassified (pre-2012) initiated 20 Oct 2009

    Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents

Timeline

11 dated events

  1. Recall initiated FDA recalls Z-1639-2010
  2. Recall initiated FDA recalls Z-1332-2011
  3. Recall initiated FDA recalls Z-1322-2011
  4. Recall initiated FDA recalls Z-1324-2011
  5. Recall initiated FDA recalls Z-1321-2011
  6. Recall initiated FDA recalls Z-1320-2011
  7. Recall initiated FDA recalls Z-1328-2011
  8. Recall initiated FDA recalls Z-1319-2011
  9. Recall initiated FDA recalls Z-1329-2011
  10. Listed FDA GUDID 08498840010907

1 earlier event are in the sections above.

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
Intravenous administration tubing extension set
Model / Ref / Catalog
VYCIS007
Primary DI / UDI-DI
08498840010907
510(k) Number
FDA product code
FPA
GMDN term
Intravenous administration tubing extension set
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intravenous administration tubing extension set

Cleared under the same submission (K011336)

and 8 more cleared under K011336

Similar devices in this category

Other devices filed under Intravenous administration tubing extension set.

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)