# K851838: Manan Chiba PTC Needle

- Pathway: 510(k) (Traditional)
- Applicant: Manan Manufacturing Co., Inc.
- Decided: Jun 21, 1985 after 56 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
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021847: Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles (2002), 11 descendants of its own
- K142688: Echotip Procore HD Ultrasound Biopsy Needle (2014), 9 descendants of its own
- K980122: Manan Soft Tissue Biopsy Needles (1998), 8 descendants of its own
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (2016), 7 descendants of its own
- K210476: EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle (2021), 2 descendants of its own

Source page: https://510kreport.com/device/K851838
Methodology: https://510kreport.com/methodology