# K962977: Mri Compatible Biopsy Needles

- Pathway: 510(k) (Traditional)
- Applicant: Manan Medical Products, Inc.
- Decided: Oct 9, 1997 after 435 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.
4 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K980211: Mri Chiba,Spinal,Breast Localization,Automatic Cutting Needles (1998), 3 descendants of its own
- 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
Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.

Source page: https://510kreport.com/device/K962977
Methodology: https://510kreport.com/methodology