Vcare Extra Large
VCARE Extra Large is a disposable uterine manipulator used during laparoscopic surgical and diagnostic procedures. It allows the clinician to position the uterus and cervix and to inject…
VCARE Extra Large is a disposable uterine manipulator used during laparoscopic surgical and diagnostic procedures. It allows the clinician to position the uterus and cervix and to inject fluids or gases during procedures such as laparoscopic hysterectomy, tubal occlusion or diagnostic laparoscopy.
The device combines an insulated manipulator tube, distal inflatable balloon and shaped handle with an extra large cervical cup. The cup retracts and elevates the cervix and provides a guide for colpotomy, while the handle controls uterine position.
Listed Item
Vcare Extra Large Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator, Uterine Manipulator
Maintaining Insufflation
An occluder seals the vagina after colpotomy to help maintain pneumoperitoneum during the procedure. The cervical cup also includes sites for suturing. VCARE is intended for a single use.
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 |
| 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 | 2022-06-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60-6085-303 | 8 | Withdrawn | |
| 60-6085-203 | 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.