# Ahto 0250070640

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/ahto-250-070-640>
- Manufacturer: [Stryker Corp.](https://devicerts.com/manufacturers/stryker-corp) (FDA registration: United States)
- Name in the registry: AHTO 0250070640
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: HET, KQT, GCX
- EMDN: Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER
- GMDN: Surgical irrigation/aspiration tubing set (47625)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 08858251005747U4 · UDI-DI 07613327061475 · registered 2026-08-18 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 07613327061475 · listed 2016-09-23 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K042454 · decision 2004-12-09 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2864-2026 · Class II · ongoing · initiated 2026-06-08: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Z-2863-2026 · Class II · ongoing · initiated 2026-06-08: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Z-2862-2026 · Class II · ongoing · initiated 2026-06-08: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Z-0836-2018 · Class II · terminated · initiated 2017-11-17: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
- Z-0279-06 ·  · terminated · initiated 2005-11-18: Devices for which sterility may be compromised as evidenced by a crack in the package.

## Identity

- Trade name: AHTO [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Surgical irrigation/aspiration tubing set [FDA GUDID (AccessGUDID)]
- Device name: ENDO\_TF10584\_ENDO16\_Suction Irrigators and accessories\_Tube Sets [EUDAMED]
- Model / Ref / Catalog: 08858251005747U4 [EUDAMED]; 250-070-640 [EUDAMED, FDA GUDID (AccessGUDID)]; 0250070640 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 07613327061475 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 08858251005747U4 [EUDAMED]
- 510(k) Number: K042454 [FDA GUDID (AccessGUDID)]
- FDA product code: HET [FDA GUDID (AccessGUDID)]; KQT [FDA GUDID (AccessGUDID)]; GCX [FDA GUDID (AccessGUDID)]
- EMDN code: Z12029099 [EUDAMED]
- GMDN term: Surgical irrigation/aspiration tubing set (47625) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 884.1720 [FDA GUDID (AccessGUDID)]; 876.4370 [FDA GUDID (AccessGUDID)]; 880.6740 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Ireland [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Ahto 0250070640, Stryker Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/ahto-250-070-640 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/ahto-250-070-640.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/ahto-250-070-640
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.