# K974446: Manan Automatic Cutting Needle

- Pathway: 510(k) (Traditional)
- Applicant: Manan Medical Products, Inc.
- Decided: Jan 8, 1998 after 44 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K981166: Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 (1998), 2 descendants of its own
- K162588: Möller Medical Biopsy Needles and Systems (2017), 1 descendant of its own
- K242128: Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (2025), 0 descendants of its own
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own
- K013109: Sonopsy (2002), 0 descendants of its own

## Indications for use
Needle can be used for obtaining core and/or aspiration biopsies of various tissues (Prostate, lung, kidney, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For Breast Biopsy this product is for diagnosis only-not for therapeutic use.

Source page: https://510kreport.com/device/K974446
Methodology: https://510kreport.com/methodology