McCarus-Volker Fornisee® System
Combo Box of (6) FS® DEVICES This set includes (2) FS-30 DEVICES - (30mm Cervical Cup), (2) FS-35 DEVICES - (35mm Cervical Cup), and (2) FS-40 DEVICES - (40mm Cervical Cup).
5manufacturers in China registered for this device type
9catalogue 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 | LSI Solutions Inc., United States |
|---|---|
| FDA product code | LKF |
| Device type | Cannula, Manipulator/Injector, Uterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Manufacturer |
| 510(k) | K111014 |
| Record published | 2016-09-23 |
| Record revised | 2022-11-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 6 |
| Sizes | Length 6 to 12 cm; outer diameter 30 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110035 | Outer Diameter 35 mm | In distribution |
| 110106 | Length 12 cm | In distribution |
| 110029 | Outer Diameter 30 mm | In distribution |
| 110112 | Length 6 cm | In distribution |
| 110105 | Length 10 cm | In distribution |
| 110056 | Length 6 cm | In distribution |
| 110040 | Outer Diameter 40 mm | In distribution |
| 110058 | Length 8 cm | In distribution |
| 110030 | Outer Diameter 30 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 39 |
| Cannula, Manipulator/Injector, Uterine | C R I | 31 |
| 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 |
| Cook | Cook Incorporated | 8 |
Showing 12 of 111. All products under Cannula, Manipulator/Injector, Uterine
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.