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InZone IST IST345100960

by Stryker Corp.

Ref IST345100960Model 08858251006940U7

InZone IST IST345100960 is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 08858251006940U7), cleared under FDA 510(k) K251832 on 17 Oct 2025 and listed in FDA GUDID since 8 Jul 2026 (UDI-DI 07613327635096), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251832

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006940U7 Basic UDI-DI 07613327635096UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327635096 UDI-DI Date8 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK251832 Date17 Oct 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251006940U7 registered 6 Oct 2026 Active
  • FDA 510(k) K251832 decided 17 Oct 2025 Active
  • FDA GUDID UDI-DI 07613327635096 listed 8 Jul 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K251832
  2. Listed FDA GUDID 07613327635096
  3. Registered EUDAMED 08858251006940U7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
InZone IST
Generic name
Vascular implant detacher, electronic, single-use
Device name
InZone IST Detachment System
Model / Ref / Catalog
IST345100960, 08858251006940U7
Primary DI / UDI-DI
07613327635096
Basic UDI-DI
08858251006940U7
510(k) Number
FDA product code
HCG, KRD
EMDN code
C010404020280 Neurovascular embolisation devices - accessories
GMDN term
Vascular implant detacher, electronic, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.5950, 870.3300
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (19, all answered No)