VenSure Nav Balloon Dilation System
Balloon Dilation system as set including navigated Balloon dilation device with bending tool and Inflation device with tubes,
11manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (2). 4 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 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Jiangsu Yongle Medical Technology Co., Ltd. | Taixing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Fiagon GMBH, Germany |
|---|---|
| FDA product code | LRC |
| Device type | Instrument, Ent Manual Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Manufacturer |
| Record published | 2022-11-10 |
| Record revised | 2026-01-12 (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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Ent Manual Surgical | Karl Storz GmbH & Co. KG | 2,062 |
| Fentex | Fentex medical GmbH | 1,738 |
| Elmed | Elmed, Inc. | 504 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 441 |
| Evonos | Gyrus Acmi, Inc. | 291 |
| Millennium | Avalign Technologies, Inc. | 283 |
| Elmed Incorporated | Elmed, Inc. | 277 |
| Instrument, Ent Manual Surgical | Stryker Leibinger Gmbh & Co. KG | 169 |
| Rhinoforce | Karl Storz GmbH & Co. KG | 112 |
| Surtex | Surtex Instruments Ltd | 85 |
| Kerrison sphenoid punch | Spiggle & Theis Medizintechnik Gmbh | 82 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 78 |
Showing 12 of 661. All products under Instrument, Ent Manual Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201472 | 2020-08-26 |
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.