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Ahto 0250070640

by Stryker Corp.

Ref 250-070-640Model 08858251005747U4

Ahto 0250070640 (250-070-640) is a surgical irrigation/aspiration tubing set (EU MDR Class IIa; FDA Class II) made by Stryker Corp., registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 08858251005747U4), cleared under FDA 510(k) K042454 on 9 Dec 2004 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07613327061475), active as of 24 Oct 2026. 5 FDA recalls are linked to it.

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

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K042454

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 Number08858251005747U4 Basic UDI-DI 07613327061475UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327061475 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK042454 Date9 Dec 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251005747U4 registered 18 Aug 2026 Active
  • FDA 510(k) K042454 decided 9 Dec 2004 Active
  • FDA GUDID UDI-DI 07613327061475 listed 23 Sep 2016 Listed

Recalls

5 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2864-2026 FDA Class II initiated 8 Jun 2026
    • Ongoing Z-2863-2026 FDA Class II initiated 8 Jun 2026
    • Ongoing Z-2862-2026 FDA Class II initiated 8 Jun 2026

    There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

    • Terminated Z-0836-2018 FDA Class II initiated 17 Nov 2017

    Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

    • Terminated Z-0279-06 FDA Unclassified (pre-2012) initiated 18 Nov 2005

    Devices for which sterility may be compromised as evidenced by a crack in the package.

Timeline

8 dated events

  1. Cleared FDA 510(k) K042454
  2. Recall initiated FDA recalls Z-0279-06
  3. Listed FDA GUDID 07613327061475
  4. Recall initiated FDA recalls Z-0836-2018
  5. Recall initiated FDA recalls Z-2864-2026
  6. Recall initiated FDA recalls Z-2863-2026
  7. Recall initiated FDA recalls Z-2862-2026
  8. Registered EUDAMED 08858251005747U4

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
Ahto
Generic name
Surgical irrigation/aspiration tubing set
Device name
ENDO_TF10584_ENDO16_Suction Irrigators and accessories_Tube Sets
Model / Ref / Catalog
08858251005747U4, 250-070-640, 0250070640
Primary DI / UDI-DI
07613327061475
Basic UDI-DI
08858251005747U4
510(k) Number
FDA product code
HET, KQT, GCX
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Surgical irrigation/aspiration tubing set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1720, 876.4370, 880.6740
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251005747U4
250-070-640
GUDID
0250070640
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.

Related devices

Category: Surgical irrigation/aspiration tubing set

Cleared under the same submission (K042454)

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)