Definition: To Achieve And Maintain Hemostasis Of A Breast Biopsy Wound Site.
| Device Type ID | 5484 |
| Device Name | Post Breast Biopsy Hemostatic Breast Compression Device |
| Physical State | The Device Is Typically A Solid Material (e.g., Plastic Block With Characteristic Geometry) That Can Adequately Interface And Compress Tissue At Or Around A Bleeding Biopsy Wound. |
| Technical Method | The Devices Are Designed To Be Used In Conjunction With Stereotactic Biopsy Platforms. |
| Target Area | The Device Generally Targets Skin Soft Tissue. |
| Regulation Description | Mammographic X-ray System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1710 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | POY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5484 |
| Device | Post Breast Biopsy Hemostatic Breast Compression Device |
| Product Code | POY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Mammographic X-ray System. |
| CFR Regulation Number | 892.1710 [🔎] |
| Device Problems | |
|---|---|
Image Display Error / Artifact | 1 |
Moisture Damage | 1 |
| Total Device Problems | 2 |