Saberscope Laparoscope (SAS-A-536L); Xenocor Video Processing Unit (VPUX-1)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K260177 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
- Models / Variants
- Saberscope™ Laparoscope (SAS-A-536L) FDA 510(k)Xenocor® Video Processing Unit (VPUX-1) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Saberscope Laparoscope (SAS-A-536L) is a laparoscope, general & plastic surgery designed for diagnostic and therapeutic endoscopic procedures. It features a 5mm rigid shaft with a 0° camera and ±90° articulating tip, enabling visualization within the thoracic and peritoneal cavities, including female reproductive organs. The device is paired with the Xenocor Video Processing Unit (VPUX-1) for image enhancement and transmission during procedures.
This system is supplied as a single-use, sterile device, intended for use in controlled surgical environments. The laparoscope’s 36cm length and articulating tip facilitate precise maneuverability, while the VPUX-1 processes video output for real-time imaging. Authorized under FDA 510(k) clearance (K260177), the device adheres to regulatory standards for general and plastic surgery laparoscopes, with no third-party review indicated.
Frequently asked questions
What types of surgical procedures is the Saberscope Laparoscope designed to assist with, and why is the articulating tip important?
The Saberscope Laparoscope (SAS-A-536L) is designed for diagnostic and therapeutic endoscopic procedures in general and plastic surgery, particularly within the thoracic and peritoneal cavities. The ±90° articulating tip allows for enhanced visualization of confined or hard-to-reach areas, such as female reproductive organs, by providing flexibility and precision during navigation. This feature is critical for improving maneuverability in tight surgical spaces where a rigid scope might limit access or visibility.
Is the Saberscope Laparoscope intended for reuse, and what does that mean for its maintenance and storage?
No, the Saberscope Laparoscope is explicitly supplied as a single-use, sterile device, meaning it is not designed for reuse. This eliminates the need for cleaning, sterilization, or maintenance between procedures, reducing the risk of contamination or damage. Clinicians should store the device in its original packaging until use and discard it immediately after a single procedure to comply with manufacturer guidelines and maintain sterility.
How does the Xenocor Video Processing Unit (VPUX-1) enhance the imaging experience during laparoscopic procedures?
The VPUX-1 is paired with the Saberscope Laparoscope to process and enhance video output in real-time, improving image clarity and transmission quality during surgery. This ensures surgeons have a sharper, more reliable visual feed, which is essential for precise navigation, especially in complex or minimally invasive procedures where visibility directly impacts outcomes.
What is the length of the laparoscope shaft, and how does this dimension impact its use in surgical settings?
The Saberscope Laparoscope features a 36cm rigid shaft, which balances reach and maneuverability in laparoscopic procedures. This length allows for adequate insertion into the thoracic and peritoneal cavities while still providing sufficient articulation at the tip to navigate around anatomical structures. The 5mm diameter also ensures compatibility with standard trocar systems used in minimally invasive surgery.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for clinicians?
The Saberscope Laparoscope and VPUX-1 system received FDA 510(k) clearance (K260177) under a Special 510(k) review, with a determination of Substantially Equivalent (SESE) to a predicate device. This means the FDA evaluated it against existing laparoscopic systems and confirmed it meets safety and effectiveness standards for general and plastic surgery applications. Clinicians can rely on this clearance as evidence of regulatory compliance, though they should always follow the manufacturer’s instructions for use.
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: Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit ..., Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit ..., Xenocor Single-Use Laparoscope - Keeping Focus on the Patient
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260177 | Class II | Active |
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Manufacturer
- Manufacturer
- Xenocor, Inc.
Sources (1)
- FDA 510(k) K260177 24 fields · synced Sep 19, 2026