# K051361: Easy Core Detachable Biopsy System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jun 16, 2005 after 22 days
- Product code: KNW (Instrument, Biopsy)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Easy Core Biopsy System: named in the summary without a submission number
- (no number) Easy Core Biopsy System II: named in the summary without a submission number
- (no number) ASAP Biopsy System (Formerly referred to as Stamey Sampler Spring Loaded Needle): named in the summary without a submission number
- (no number) ASAP 14g Biopsy System: named in the summary without a submission number

## Indications for use
The Easy Core Detachable Biopsy System is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs/tumors or masses for histological analysis. Soft tissue sampling includes but is not limited to organs such as breast, liver, kidney and prostate.

Source page: https://510kreport.com/device/K051361
Methodology: https://510kreport.com/methodology