V-Core Full Core Breast Biopsy Instrument
by Medical Device Technologies, Inc.
510(k) K042464
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042464 | Date30 Sep 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNW
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The V-Core Full Core Breast Biopsy Instrument is a core biopsy device designed for obtaining intact tissue samples from breast lesions. It employs a tri-axial cutting system with an integrated pincher-style capture mechanism within the outer cannula to ensure stable, high-quality specimen retrieval. This device is intended for use in diagnostic procedures where precise, undamaged tissue cores are required for histopathological examination. Its design minimizes sample fragmentation or displacement, improving diagnostic accuracy.
The instrument is supplied as a reusable medical device and is intended for use in clinical settings such as radiology or surgical suites. It requires sterile preparation prior to use and is regulated under FDA 510(k) clearance (K042464) as substantially equivalent to predicate devices. No specific MRI safety classification or single-use designation is noted in the regulatory data. Storage and handling follow standard aseptic protocols for reusable surgical instruments.