# K052802: Manan Bio-Cut Soft Tissue Biopsy Needle

- Pathway: 510(k) (Special)
- Applicant: Manan Medical Products, Inc.
- Decided: Nov 1, 2005 after 29 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: 2 generations back to K950732 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950732: Manan Super-Core Biopsy Needle, Manan Medical Products, Inc. (1995) Summary page 1.
- K974814: Manan (TM) Super-Core Biopsy Needles, Medical Device Technologies, Inc. (1998) Summary page 1.

## Most influential descendants
- K080674: Pajunk's Primocut Disposable Biopsy System (2008), 0 descendants of its own

## Indications for use
The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.

Source page: https://510kreport.com/device/K052802
Methodology: https://510kreport.com/methodology