# K974814: Manan (TM) Super-Core Biopsy Needles

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Jan 9, 1998 after 17 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950732 (1995). 1 ancestor in all.
30 later devices descend from it; 5 cite it directly.
0 of 32 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.

## Most influential descendants
- K051506: Mielo-Can, Best-Lisas, Ben - Bone Biopsy.  Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy (2005), 18 descendants of its own
- K131157: Ranfac Bone Marrow Aspiration Needle (2013), 12 descendants of its own
- K161409: M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem (2016), 6 descendants of its own
- K171953: Bard Mission Disposable Core Biopsy Instrument (2017), 5 descendants of its own
- K140991: Ranfac Aspiration Needle with Adjustable Guide (2014), 5 descendants of its own

## Recalls of this device
- Oct 4, 2021 · Class II · Z-0354-2022: Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.

## Indications for use
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.

Source page: https://510kreport.com/device/K974814
Methodology: https://510kreport.com/methodology