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HistoSonics HISKT2000

by Histosonics, Inc

HistoSonics HISKT2000 is a combination water purification system made by Histosonics, Inc, listed in FDA GUDID since 29 Jul 2024 (UDI-DI 00850006962129), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850006962129 UDI-DI Date29 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
HistoSonics
Generic name
Combination water purification system
Model / reference
HISKT2000
Primary DI / UDI-DI
00850006962129
GMDN term
Combination water purification system
GUDID distribution status
In Commercial Distribution

Related devices

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Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)