# K974741: Manan Accura Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Jan 8, 1998 after 20 days
- Product code: GAA (Needle, Aspiration And Injection, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K863848 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863848: Manan Brest Tumor Localization Needle, Manan Manufacturing Co., Inc. (1986) Summary page 1.

## Recalls of this device
- Sep 1, 2009 · Not classified · Z-2017-2010: Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Acces

## Indications for use
The Manan™ Accura needle is intended for use as a needle localization of breast lesions.

Source page: https://510kreport.com/device/K974741
Methodology: https://510kreport.com/methodology