Vcare Small
VCARE Small is a single use uterine manipulator and cervical retractor used during laparoscopic surgery and diagnostic procedures. It positions the uterus, retracts and elevates the cervix,…
VCARE Small is a single use uterine manipulator and cervical retractor used during laparoscopic surgery and diagnostic procedures. It positions the uterus, retracts and elevates the cervix, and provides a route for injecting fluids or gases. Its uses include laparoscopic hysterectomy, tubal occlusion and diagnostic laparoscopy.
The device has an insulated manipulator tube with an inflatable balloon and an anatomically shaped handle. The small cervical cup supports manipulation and provides a guide for colpotomy, with sites for suturing. An occluder seals the vagina after colpotomy to help maintain the pneumoperitoneum.
Listed Item
Vcare Small Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator, Uterine Manipulator
Positioning References
Centimeter graduations on the manipulator tube provide a reference for comparison with a graduated uterine sound. The cervical cup and handle work together to maintain the selected position of the uterus during the procedure.
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 10 to 32 °C; Storage environment temperature 50 to 90 °F |
| Packaging | Box of 8 |
| Distribution end date | 2024-10-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60-6085-300 | 8 | Withdrawn | |
| 60-6085-200 | 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.