Vascular Clamp
by T. Korossurgical Instruments Corp. 510(k)
Active
510(k) K881158
Overview
The Vascular Clamp is a hand-held, manual open-surgery instrument classified as a vascular clamp (Device Type: DXC). It is designed to securely grasp and manipulate soft tissues, including blood vessels, during surgical procedures. The instrument features a tweezers-like mechanism with interchangeable or fixed tips to accommodate various anatomical applications. Its primary function is to provide controlled occlusion or stabilization of vascular structures without causing damage.
This device is supplied sterile for single-use in controlled surgical environments. It is intended for use in open-surgery settings and must comply with standard surgical aseptic techniques. The Vascular Clamp holds an FDA 510(k) clearance (K881158) under the Cardiovascular (CV) advisory committee, confirming its regulatory compliance for vascular applications. Storage requires adherence to manufacturer guidelines for sterile packaging integrity, and its design ensures compatibility with standard surgical workflows.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881158 | Date20 Jun 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from T. Korossurgical Instruments Corp.
Questions
What is the primary purpose of the T. Koros Vascular Clamp?
The T. Koros Vascular Clamp is designed to securely grasp and stabilize blood vessels or soft tissues during open surgical procedures. Its tweezers-like mechanism allows controlled occlusion or stabilization without damaging vascular structures, making it ideal for cardiovascular and vascular surgeries where precise manipulation is required.
Is the T. Koros Vascular Clamp intended for single-use or reuse?
The T. Koros Vascular Clamp is supplied sterile and intended for single-use only. This ensures patient safety by maintaining aseptic conditions in controlled surgical environments, adhering to standard surgical aseptic techniques.
How should the Vascular Clamp be stored to maintain sterility?
The device must be stored according to the manufacturer’s guidelines to preserve the integrity of its sterile packaging. This includes keeping it in a clean, dry environment away from direct sunlight or extreme temperatures, ensuring it remains unopened until use.
Does the T. Koros Vascular Clamp come with interchangeable or fixed tips?
The Vascular Clamp features a tweezers-like mechanism with interchangeable or fixed tips, allowing surgeons to select the appropriate tip for specific anatomical applications. This versatility enhances its adaptability during surgical procedures.
What regulatory compliance does the T. Koros Vascular Clamp hold?
The device holds FDA 510(k) clearance (K881158) under the Cardiovascular (CV) advisory committee, confirming its regulatory compliance for vascular applications. This clearance was granted in 1988, validating its substantial equivalence to predicate devices.