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510(k) Data Aggregation
K Number
K230836Device Name
SchurSign Tissue Marker
Manufacturer
Date Cleared
2024-01-23
(302 days)
Product Code
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
SurgMark GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Under supervision of a healthcare professional
· The SchurSign Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description
SchurSign Tissue Marker consists of a radiographic soft tissue marker and a delivery system. SchurSign is a sterile, single patient use, discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI).
The proposed SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location.
The proposed SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate.
The proposed SchurSign Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the SchurSign Tissue Marker.
The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a bevelled 12 cm / 14 to 10 gauge needle with 1 cm depth marks and a plunger.
SchurSign is available in seven different sizes:
| Model | Diameter (mm) | Length (mm) |
|------------------|---------------|-------------|
| SchurSign 1.5-5 | 1.5 | 5 |
| SchurSign 1.5-8 | 1.5 | 8 |
| SchurSign 2.0-5 | 2.0 | 5 |
| SchurSign 2.0-8 | 2.0 | 8 |
| SchurSign 2.0-10 | 2.0 | 10 |
| SchurSign 2.5-10 | 2.5 | 10 |
| SchurSign 3.0-10 | 3.0 | 10 |
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