Koala Vascular Clamps and Inserts
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980002 FDA 510(k)
- FDA Product Code
- DXC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Koala Vascular Clamps and Inserts are vascular clamps designed to occlude blood vessels during surgical procedures. These devices are intended for use in cardiovascular applications, providing controlled compression to isolate vascular segments while maintaining tissue integrity.
Supplied as reusable surgical instruments, the Koala Vascular Clamps and Inserts are intended for use in sterile operating room environments. They are classified under FDA product code DXC and were granted Substantially Equivalent (SESE) clearance via a Traditional 510(k) pathway in 1998. Sizes and configurations are specified in the original submission but are not detailed in the provided data.
Frequently asked questions
Are the Koala Vascular Clamps and Inserts designed for single-use or can they be reused in multiple procedures?
The Koala Vascular Clamps and Inserts are explicitly labeled as reusable surgical instruments. Since they are intended for use in sterile operating room environments, they must be properly cleaned, sterilized, and maintained between procedures to ensure safety and functionality. Reusability is a key design feature to support cost-effective surgical workflows.
What type of surgical procedures are these clamps primarily intended for, and why?
These clamps are designed for cardiovascular applications, specifically to occlude blood vessels during surgery. Their controlled compression allows surgeons to isolate vascular segments while preserving tissue integrity—a critical function in procedures like bypass surgeries, aneurysm repairs, or other interventions requiring precise vascular control.
How were the regulatory approvals for the Koala Vascular Clamps and Inserts obtained, and what does that mean for their use?
The device received Substantially Equivalent (SESE) clearance via a Traditional 510(k) pathway in 1998, reviewed by the FDA’s Cardiovascular (CV) Advisory Committee. This means the manufacturer demonstrated that the clamps are not significantly different from a legally marketed predicate device in terms of safety and effectiveness for their intended use in occluding blood vessels. Clinicians can rely on this approval as evidence of regulatory scrutiny for cardiovascular surgical applications.
What does the product code *DXC* indicate about how these clamps are classified and regulated?
*DXC* is the FDA’s product classification code for vascular clamps, indicating these devices fall under vascular surgery instruments. This classification ensures they meet specific regulatory requirements for surgical tools used to occlude or manipulate blood vessels, including performance standards and labeling mandates. The code helps streamline submissions and compliance checks for similar devices.
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: KOALA VASCULAR CLAMPS AND INSERTS - Innolitics, Boss Instruments, Ltd. FDA 510 (k) Products (1998-1998), KOALA VASCULAR CLAMPS AND INSERTS 510(k) K980002 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980002 | Class II | Active |
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Manufacturer
- Manufacturer
- Boss Instruments, Ltd.
Sources (1)
- FDA 510(k) K980002 24 fields · synced Sep 18, 2026