TruClear
Operative Hysteroscope 5C, Refurbished
13manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (4), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Ningbo Skonsin Electronics Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Shanghai AnQing Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Guangdong EO Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Suzhou Acuvu Medical Technology Co., Ltd. | Suzhou | Jiangsu | Specification developer | 4 |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou | Jiangsu | Specification developer | 3 |
Showing 12 of 13. All 13 manufacturers in China registered for Hysteroscope (And Accessories)
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | HIH |
| Device type | Hysteroscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1690 |
| 510(k) | K180496 |
| Record published | 2018-12-21 |
| Record revised | 2025-06-24 (version 13) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 20 to 90 % RH; Storage environment temperature -4 to 140 °F; Handling environment temperature 50 to 104 °F; Handling environment humidity 30 to 70 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Case of 999, pack_or_inner_pack of 5, case of 80 |
| Sizes | Outer diameter 3 to 9 mm; length 2.9 to 4 mm |
| Distribution end date | 2026-03-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 72205051 | In distribution | ||
| 7209807 | In distribution | ||
| 72204064 | In distribution | ||
| 7209509 | In distribution | ||
| 7205561 | 5 | In distribution | |
| 72204752S | Outer Diameter 5 mm | In distribution | |
| 7209808S | In distribution | ||
| 7209208S | Outer Diameter 8 mm | In distribution | |
| 72204752 | In distribution | ||
| 7209807S | In distribution | ||
| 72204752 | Outer Diameter 5 mm | In distribution | |
| 72204753 | Outer Diameter 5.7 mm | In distribution | |
| 72203606 | Length 4.0 mm | In distribution | |
| 72203012 | In distribution | ||
| 72203506 | Length 2.9 mm | In distribution | |
| 7209808 | In distribution | ||
| 72205067 | Outer Diameter 4 mm | In distribution | |
| 72205066 | Outer Diameter 3 mm | In distribution | |
| 72204879 | Outer Diameter 7.25 mm | In distribution | |
| 72204753 | In distribution | ||
| 72204878S | In distribution | ||
| 72202977 | Outer Diameter 5.6 mm | In distribution | |
| 72204879S | In distribution | ||
| 7209820 | In distribution | ||
| 72202536 | In distribution | ||
| 72204878 | Outer Diameter 6 mm | In distribution | |
| 7209383 | Outer Diameter 9 mm | Withdrawn | |
| 7209384 | Withdrawn | ||
| 7209208 | Outer Diameter 8 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hysteroscope (And Accessories) | Karl Storz GmbH & Co. KG | 255 |
| AED | National Advanced Endoscopy Devices, Inc. | 79 |
| USA Elite | Gyrus Acmi, Inc. | 79 |
| Olympus | Olympus Winter & IBE Gmbh | 57 |
| Hysteroscope (And Accessories) | Stryker GmbH | 42 |
| Hysteroscopy sheath | Sopro-Comeg GmbH | 28 |
| Hysteroscope (And Accessories) | Richard Wolf Gmbh | 24 |
| Hysteroscope | Sopro-Comeg GmbH | 18 |
| Elite 2 System | Gyrus Acmi, Inc. | 17 |
| Gynecare Versapoint | Ethicon, Inc. | 16 |
| USA Elite System | Gyrus Acmi, Inc. | 11 |
| SlimLine | Gyrus Acmi, Inc. | 10 |
Showing 12 of 177. All products under Hysteroscope (And Accessories)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2022-06-07 | Class II | Device Design | Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch. | 33 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.