# K980004: Manan General Purpose Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Jan 9, 1998 after 7 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 K881957 (1988). 2 ancestors in all.
3 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)
- K940024: Manan General Purpose Introducer Needle, Manan Medical Products, Inc. (1994) Summary page 1.
- K881957: Hawkins-Akins Blunt Needle Access Kit, N-S Medical Products (1988) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Manan™ Co-Axial Introducer Needle is intended for a range of biopsy applications of soft tissue.

Source page: https://510kreport.com/device/K980004
Methodology: https://510kreport.com/methodology