# K963813: Sure Core Biopsy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Interventional Concepts, Inc.
- Decided: Mar 20, 1997 after 178 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.
34 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K012023: Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable (2001), 31 descendants of its own
- K022314: Sanarus Visica Treatment System (2002), 29 descendants of its own
- K052861: Modification to:Sanarus Visica Treatment System , Models VS2000 (2005), 28 descendants of its own
- K061510: Sanarus Visica Treatment System (2006), 27 descendants of its own
- K062896: V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600 (2007), 26 descendants of its own

## Indications for use
used to cut soft tissue for the purpose of obtain a biopsy sample

Source page: https://510kreport.com/device/K963813
Methodology: https://510kreport.com/methodology