Cannula, Manipulator/Injector, Uterine
Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based contrast media
5manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing | Beijing | Manufacturer | 5 |
Record
| Listed by | C R I |
|---|---|
| FDA product code | LKF |
| Device type | Cannula, Manipulator/Injector, Uterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| 510(k) | K032835 |
| Record published | 2016-10-10 |
| Record revised | 2018-12-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep out of direct sunlight; Special storage condition: Keep Dry |
| Packaging | Box of 10, box of 12 |
| Sizes | Catheter gauge 5 to 7 Fr; length 23 to 37 cm; outer diameter 2 to 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HSG Tray | Catheter Gauge 7 Fr | In distribution |
| HS Catheter w/Depth Marks, 7F | Length 28 cm | In distribution |
| Steen HS Catheter, 7F | Length 28 cm | In distribution |
| EZ Glide Manipulator | Outer Diameter 5 mm | In distribution |
| K-UMI | Length 33 cm | In distribution |
| Steen HS Catheter, 5F | Catheter Gauge 5 Fr | In distribution |
| 5F Shapeable HS Catheter | Catheter Gauge 5 Fr | In distribution |
| 7F HS Catheter | Catheter Gauge 7 Fr | In distribution |
| Stylet | In distribution | |
| 7F Shapeable HS Catheter | Length 28 cm | In distribution |
| Uterine Manipulator | Length 33 cm | In distribution |
| 5F HS Catheter | Catheter Gauge 5 Fr | In distribution |
| Uterine Injector, 2.0 | Outer Diameter 2 mm | In distribution |
| Uterine Injector, 4.0 | Outer Diameter 4 mm | In distribution |
| 5F HS Catheter | Length 28 cm | In distribution |
| 5F Shapeable HS Catheter | Length 28 cm | In distribution |
| 7F HS Catheter | Length 28 cm | In distribution |
| Two-Tap HS Catheter, 7F | Length 28 cm | In distribution |
| HSG Tray | Catheter Gauge 5 Fr | In distribution |
| HS Catheter w/Depth Marks, 5F | Catheter Gauge 5 Fr | In distribution |
| 7F Shapeable HS Catheter | Catheter Gauge 7 Fr | In distribution |
| Two-Tap HS Catheter, 5F | Catheter Gauge 5 Fr | In distribution |
| Two-Tap Shapeable HS Catheter, 5F | Length 28 cm | In distribution |
| eZinject Catheter | In distribution | |
| eZinject Catheter | In distribution | |
| HSG Tray | Catheter Gauge 7 Fr | In distribution |
| Sonoinject, 5F | Catheter Gauge 5 Fr | In distribution |
| HSG Tray | Catheter Gauge 5 Fr | In distribution |
| Two-Tap Shapeable HS Catheter, 7F | Catheter Gauge 7 Fr | In distribution |
| HSG Tray | In distribution | |
| Stylet | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 39 |
| Marina Medical | Marina Medical Instruments, Inc. | 29 |
| HSG Catheter | Titus Medical LLC | 26 |
| HNM Women Care | HNM Stainless, LLC. | 20 |
| Bioteque | Bioteque Taiwan Ltd. | 16 |
| Viky | Endocontrol | 15 |
| Cannula, Manipulator/Injector, Uterine | Panpac Medical Corporation | 14 |
| Uterine ElevatOR Pro | THE O R Company PTY Ltd | 12 |
| Valtchev Uterine Mobilizer | Conkin Surgical Instruments Ltd. | 10 |
| Novo Surgical | Novo Surgical, Inc. | 9 |
| McCarus-Volker Fornisee® System | LSI Solutions Inc. | 9 |
| Cook | Cook Incorporated | 8 |
Showing 12 of 111. All products under Cannula, Manipulator/Injector, Uterine
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 | Closed |
|---|---|---|---|---|---|---|---|
| Biomerics | 510(k) number | 2006-04-24 | Not classified | Other | The uterine stop component was not included with the device. | 660 | 2007-12-04 |
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.