# K980211: Mri Chiba,Spinal,Breast Localization,Automatic Cutting Needles

- Pathway: 510(k) (Traditional)
- Applicant: Manan Medical Products, Inc.
- Decided: Feb 6, 1998 after 16 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
Longest line of descent: 1 generation back to K962977 (1997). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962977: Mri Compatible Biopsy Needles, Manan Medical Products, Inc. (1997) Summary page 1.

## Most influential descendants
- K063697: Special Sprotte, Chiba, DR Steinhoff Kit (2007), 1 descendant of its own
- K113209: Chiba Sono (2011), 0 descendants of its own
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

## Indications for use
These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating. The breast localization needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.

Source page: https://510kreport.com/device/K980211
Methodology: https://510kreport.com/methodology