Ahto
Disposable Suction/Irrigator Tube Set, Dual Spike
7manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K042454 |
| Record published | 2016-09-23 |
| Record revised | 2019-04-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0250070640 | In distribution | |
| 0250070620 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoplus | Endoplus | 448 |
| Integra® MicroFrance® | Integra Microfrance SAS | 273 |
| Symmetry Surgical® | Aspen Surgical Products, Inc. | 139 |
| Laparoscope, Gynecologic (And Accessories) | Karl Storz GmbH & Co. KG | 119 |
| Elmed | Elmed, Inc. | 96 |
| Olympus | Olympus Winter & IBE Gmbh | 71 |
| Core Dynamics | ConMed Corporation | 52 |
| Symmetry | Aspen Surgical Products, Inc. | 48 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 45 |
| Laparoscope, Gynecologic (And Accessories) | Richard Wolf Gmbh | 37 |
| Take-Apart | Karl Storz GmbH & Co. KG | 31 |
| Blueendo | Trokamed Gmbh | 28 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Endoscopy | 510(k) number | 2026-06-08 | Class II | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | 46,212 units | |
| Stryker Endoscopy | 510(k) number | 2026-06-08 | Class II | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | 41,052 units | |
| Stryker Endoscopy | 510(k) number | 2026-06-08 | Class II | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | 2,739 of units | |
| Stryker Endoscopy | 510(k) number | 2017-11-17 | Class II | Under Investigation by firm | Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | 60,753 units total | 2024-01-29 |
| Stryker Endoscopy | 510(k) number | 2005-11-18 | Not classified | Other | Devices for which sterility may be compromised as evidenced by a crack in the package. | 48405 boxes, 6 units per box | 2006-11-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.