Vcare Large
The listed VCARE Large is the Large (L) cervical-cup size in the FDA-described VCARE retractor/elevator, a disposable, single-use device for uterine and cervical manipulation. The device…
The listed VCARE Large is the Large (L) cervical-cup size in the FDA-described VCARE retractor/elevator, a disposable, single-use device for uterine and cervical manipulation.
The device has an insulated manipulator tube with an inflatable distal balloon and a cannula/handle. Graduations along the tube guide comparison with a graduated uterine sound.
Listed Item
Vcare Large Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator, Uterine Manipulator
Cervical Cup
The filing says the cup manipulates the uterus and retracts and elevates the cervix. It lists Small, Medium, Large and Extra-Large cup variations; the cups are green and provide a colpotomy guide.
Use Described in the Filing
VCARE is indicated for uterine manipulation and injection of fluids or gases during laparoscopic procedures, including LAVH, TLH, minilap, tubal occlusion and diagnostic laparoscopy.
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 | ConMed Corporation, United States |
|---|---|
| FDA product code | LKF |
| Device type | Cannula, Manipulator/Injector, Uterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K142716 |
| Record published | 2016-09-24 |
| Record revised | 2022-06-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 50 to 90 °F; Storage environment temperature 10 to 32 °C |
| Packaging | Box of 8 |
| Distribution end date | 2023-03-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60-6085-302 | 8 | Withdrawn | |
| 60-6085-202 | 8 | Withdrawn |
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 |
| McCarus-Volker Fornisee® System | LSI Solutions Inc. | 9 |
Showing 12 of 111. All products under Cannula, Manipulator/Injector, Uterine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142716 | 2015-02-10 |
| K093556 | 2010-03-12 |
| K071907 | 2007-10-05 |
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.