# K033205: Manoa Breast Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Manoa Medical, Inc.
- Decided: Feb 18, 2004 after 139 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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) EnCapsule: named in the summary without a submission number
- (no number) Mammotome Hand-Held: named in the summary without a submission number
- (no number) Easy Guide: named in the summary without a submission number
- (no number) Coated Electrodes: named in the summary without a submission number
- (no number) SiteSelect: named in the summary without a submission number

## Indications for use
The Manoa Breast Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure. It is for diagnostic purposes only and is not intended for therapeutic use.

Source page: https://510kreport.com/device/K033205
Methodology: https://510kreport.com/methodology