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Vaku-8 25 G X ¾"

by Hindustan Syringes and Medical Devices Limited

Vaku-8 25 G X ¾" (02347) is a Class II device made by Hindustan Syringes and Medical Devices Limited, cleared under FDA 510(k) K000592 on 12 Apr 2001 and listed in FDA GUDID since 9 Jan 2017 (UDI-DI 08903347023478), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K000592

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 Number08903347023478 UDI-DI Date9 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK000592 Date12 Apr 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000592 decided 12 Apr 2001 Active
  • FDA GUDID UDI-DI 08903347023478 listed 9 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000592
  2. Listed FDA GUDID 08903347023478

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vaku-8
Generic name
Venous butterfly needle/set
Model / Ref / Catalog
25 G X ¾", 02347
Description
VAKU-8 Blood Collection Set, 25G X ¾" (0.50X19MM) 12" TUBE MYCO REORDER # SVMS-25A
Primary DI / UDI-DI
08903347023478
510(k) Number
FDA product code
FPA
GMDN term
Venous butterfly needle/set
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Venous butterfly needle/set

Cleared under the same submission (K000592)

and 5 more cleared under K000592

Similar devices

Other devices filed under FDA product code FPA (Set, Administration, Intravascular).

Other devices from Hindustan Syringes and Medical Devices Limited

  • Vaku-8+ 23g X ¾"

    Class II

  • Unolok 22g X ¾"

    Class II

  • Vaku-8 23 G X ¾"

    Class II

  • Unolok+ 21 G X ¾"

    Class II

See all devices from Hindustan Syringes and Medical Devices Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)