# K050135: K-C Hemostatic Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Bioengineering Consultants, Ltd.
- Decided: Jul 13, 2005 after 173 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P010049 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P010049: Quickseal Femoral Arterial Closure System, Sub-Q, Inc. (2002) Summary page 2.
- (no number) Modified MENGHINI Needle for Aspiration Biopsy: named in the summary without a submission number
- (no number) Jamshidi Menghini soft Tissue Biopsy Tray: named in the summary without a submission number
- (no number) Jamshidi Soft Tissue Biopsy Needle/Syringe: named in the summary without a submission number
- (no number) Bard Max-Core Disposible Biopsy System: named in the summary without a submission number
- (no number) Temno Biopsy System: named in the summary without a submission number
- (no number) Coaxial Quick-Core Biopsy Sets: named in the summary without a submission number
- (no number) ASAPTM Automated Biopsy System: named in the summary without a submission number

## Indications for use
The K-C Hemostatic Biopsy System is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs/tumors or masses for histological analysis and deliver a hemostatic material to the biopsy site to reduce bleeding from the biopsy site. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate. It is not intended for use in bone.

Source page: https://510kreport.com/device/K050135
Methodology: https://510kreport.com/methodology