SchurSign
SchurSign is a radiographic marker intended to mark a surgical location in soft tissue. Its delivery system places the marker during open, percutaneous or endoscopic procedures, with the…
SchurSign is a radiographic marker intended to mark a surgical location in soft tissue. Its delivery system places the marker during open, percutaneous or endoscopic procedures, with the marker retained in the device until placement is desired.
The filing describes a preloaded, sterile, single-patient-use delivery system with a cannula, handle, push rod, plunger and end cap. It identifies the marker material as chitosan filled with barium sulfate and lists marker sizes by diameter and length.
Listed Item
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). SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location. SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate. 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.
Delivery System
The delivery device has a bevelled needle with depth marks and a plunger for marker placement. The filing lists seven marker sizes, including 1.5 mm and 2.0 mm diameters in different lengths.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Surgmark Gmbh, Germany |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Manufacturer |
| 510(k) | K230836 |
| Record published | 2024-11-29 |
| Record revised | 2024-12-19 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SchurSign 1.5-5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HydroMARK | Devicor Medical Products, Inc. | 75 |
| Scout® | Merit Medical Systems, Inc. | 68 |
| Scout MD™ | Merit Medical Systems, Inc. | 46 |
| SmartClip | Elucent Medical Inc. | 37 |
| BiomarC® | Carbon Medical Technologies, Inc. | 25 |
| HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 21 |
| SecurMark | Hologic, Inc. | 15 |
| Gold Marker | Riverpoint Medical LLC | 15 |
| MammoStar™ | Carbon Medical Technologies, Inc. | 15 |
| SecurMark for Atec | Hologic, Inc. | 15 |
| SenoMark® Ultra Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 14 |
| TriMark | Hologic, Inc. | 14 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230836 | 2024-01-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.