Olympus
Video telescope "ENDOEYE HD II", 5.4 mm, 30°, autoclavable
7manufacturers in China registered for this device type
71catalogue numbers in this listing
1510(k) clearance
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 | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K944200 |
| Record published | 2016-09-21 |
| Record revised | 2025-11-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2024-05-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WA64730L | In distribution | |
| WA4KL100 | In distribution | |
| WA4KL500 | In distribution | |
| WA64730A | In distribution | |
| WA64830S | In distribution | |
| WA4KL130 | In distribution | |
| A64080A | In distribution | |
| WA4KL145 | In distribution | |
| WA50040A | In distribution | |
| WA4KL545 | In distribution | |
| WA50050A | In distribution | |
| WA50042A | In distribution | |
| WA50052A | In distribution | |
| A64070A | In distribution | |
| WA4KL530 | In distribution | |
| WA63124A | Withdrawn | |
| A65050A | Withdrawn | |
| WA65040A | Withdrawn | |
| WA68170A | Withdrawn | |
| A63033A | Withdrawn | |
| A63810L | Withdrawn | |
| WA63780A | Withdrawn | |
| WA63193L | Withdrawn | |
| WA63173A | Withdrawn | |
| WA63034A | Withdrawn | |
| WA63183A | Withdrawn | |
| A63043A | Withdrawn | |
| WA63014A | Withdrawn | |
| WA63170A | Withdrawn | |
| WA63190A | Withdrawn | |
| A63120A | Withdrawn | |
| A63833A | Withdrawn | |
| WA63150L | Withdrawn | |
| A63010L | Withdrawn | |
| WA63054A | Withdrawn | |
| A63620A | Withdrawn | |
| A63610S | Withdrawn | |
| A63823S | Withdrawn | |
| WA63044A | Withdrawn | |
| A63613L | Withdrawn | |
| A63023A | Withdrawn | |
| WA63153A | Withdrawn | |
| A65020A | Withdrawn | |
| WA63142A | Withdrawn | |
| WA63084A | Withdrawn | |
| A63813S | Withdrawn | |
| WA63134A | Withdrawn | |
| WA63180A | Withdrawn | |
| A66070A | Withdrawn | |
| A63080A | Withdrawn | |
| A63070A | Withdrawn | |
| WA63024A | Withdrawn | |
| A63013S | Withdrawn | |
| A65070A | Withdrawn | |
| A63013A | Withdrawn | |
| WA63192A | Withdrawn | |
| A63843A | Withdrawn | |
| WA63074A | Withdrawn | |
| WA63122A | Withdrawn | |
| WA63163L | Withdrawn | |
| WA63160L | Withdrawn | |
| A65060A | Withdrawn | |
| WA63154A | Withdrawn | |
| A63820L | Withdrawn | |
| A63813A | Withdrawn | |
| A63610A | Withdrawn | |
| WA63132A | Withdrawn | |
| A63123A | Withdrawn | |
| WA63144A | Withdrawn | |
| WA63012A | Withdrawn | |
| A63823A | Withdrawn |
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 |
| 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 |
| Olmypus | Olympus Winter & IBE Gmbh | 23 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190744 | 2019-08-29 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2023-11-06 | Class II | Component design/selection | Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur. | WA50040A : 561 units; WA50042A: 857 units |
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.