Berkeley VC-10 Vacuum Curettage System
FDA 510(k)Class II (US FDA 510(k))
by Gyrus Acmi
Identifiers
- 510(k) Number
- K171440 FDA 510(k)
- FDA Product Code
- HHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5070 FDA 510(k)
- Regulation Number
- 884.5070 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Berkeley VC-10 Vacuum Curettage System is a Vacuum Curettage System designed for obstetric and gynecologic procedures. It employs vacuum suction to remove uterine contents, typically used in first-trimester abortions, incomplete abortions, or gestational trophoblastic disease management. The device integrates a high-vacuum pump and disposable cannulas to safely and efficiently evacuate tissue while minimizing trauma to the uterine lining. Its classification aligns with obstetrics/gynecology medical specialties and adheres to regulatory standards for reproductive health interventions.
The system is supplied as an integral unit, including a vacuum pump and foot pedal, and is intended for single-use applications in clinical settings. It operates with a maximum vacuum of 71 cm Hg (94.7 kPa) and a safe working load of 57 kg (125 lb). Sterility is maintained through disposable components, and the device is regulated under FDA 510(k) clearance (K171440) as substantially equivalent to predicate devices. Storage requires adherence to manufacturer guidelines for electrical and mechanical components, while disposable parts must be handled per sterile procedure protocols.
Frequently asked questions
What clinical procedures is the Berkeley VC-10 Vacuum Curettage System primarily used for?
The Berkeley VC-10 is designed for obstetric and gynecologic procedures involving uterine tissue removal, such as first-trimester abortions, incomplete abortions, and managing gestational trophoblastic disease. Its vacuum suction mechanism helps evacuate uterine contents while minimizing trauma to the uterine lining, making it suitable for these specific reproductive health interventions.
Is the Berkeley VC-10 Vacuum Curettage System intended for single-use or repeated use in clinical settings?
The system is explicitly intended for single-use applications in clinical settings. Sterility is maintained through its disposable cannulas and components, ensuring compliance with sterile procedure protocols for each use.
What vacuum pressure does the Berkeley VC-10 generate, and how does this affect its clinical performance?
The device generates a maximum vacuum of 71 cm Hg (94.7 kPa), which provides sufficient suction to efficiently remove uterine tissue while balancing safety and precision. This pressure range is optimized for procedures like first-trimester abortions and incomplete abortions, where controlled evacuation is critical.
How should the reusable components of the Berkeley VC-10 be stored, and what precautions should be taken?
The reusable electrical and mechanical components (e.g., vacuum pump and foot pedal) must be stored according to the manufacturer’s guidelines to maintain functionality and safety. Since the system is not single-use, proper storage conditions—such as clean, dry environments and protection from physical damage—are essential to ensure reliable performance when reused. Disposable parts, however, must be handled as sterile items per clinical protocols.
What regulatory pathway was followed for the Berkeley VC-10’s FDA clearance, and what does this mean for clinicians?
The Berkeley VC-10 received FDA 510(k) clearance (K171440) under a *Special* classification, determined to be substantially equivalent to predicate devices. This means the FDA reviewed it through the 510(k) process, ensuring it meets established safety and effectiveness standards for vacuum curettage systems in obstetrics/gynecology. Clinicians can rely on this clearance as evidence of regulatory scrutiny aligned with existing industry practices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Berkeley System (VC-10) | Olympus America | Medical, GYRUS ACMI VC-10 Berkeley Vacuum Curettage System, University of California, Berkeley – Wikipedia, PDF GYRUS ACMI REF VC-10 (115VAC, 60 Hz) Berkeley® VC®-10 Vacuum Curettage ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171440 | Class II | Active |
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Manufacturer
- Manufacturer
- Gyrus Acmi
Sources (1)
- FDA 510(k) K171440 24 fields · synced Sep 20, 2026