# K970152: Biopsy Tray

- Pathway: 510(k) (Traditional)
- Applicant: Medcare Medical Group, Inc.
- Decided: Mar 5, 1997 after 48 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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) Basic Stereotactic Core Kit: named in the summary without a submission number

## Indications for use
The Biopsy Tray is a single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures.

Source page: https://510kreport.com/device/K970152
Methodology: https://510kreport.com/methodology