# K980122: Manan Soft Tissue Biopsy Needles

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Jan 30, 1998 after 16 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 K851831 (1985). 8 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944837: Medical Device Technologies Manual Biopsy Needle, Medical Device Technologies, Inc. (1994) Summary page 1.
- K851831: Manan Franseene Needle, Manan Manufacturing Co., Inc. (1985) Summary page 1.
- K851835: Manan Greene Needle, Manan Manufacturing Co., Inc. (1985) Summary page 1.
- K851837: Manan Westcott Needle, Manan Manufacturing Co., Inc. (1985) Summary page 1.
- K851838: Manan Chiba PTC Needle, Manan Manufacturing Co., Inc. (1985) Summary page 1.
- K852426: Manan Trocar Style Biopsy Needle, Manan Manufacturing Co., Inc. (1985) Summary page 1.
- K852427: Manan Spinal Needle, Manan Manufacturing Co., Inc. (1985) Summary page 1.
- K873208: Manan Turner Style Needle, Manan Manufacturing Co., Inc. (1987) Summary page 1.

## Most influential descendants
- K041638: Targetscan Biopsy Kit (2004), 2 descendants of its own
- K162588: Möller Medical Biopsy Needles and Systems (2017), 1 descendant of its own
- K073399: Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide (2007), 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
- K150625: Morrison Steerable Needle (2015), 0 descendants of its own

## Indications for use
The Manan™ Soft Tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.

Source page: https://510kreport.com/device/K980122
Methodology: https://510kreport.com/methodology