# K031344: Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ranfac, Corp.
- Decided: May 23, 2003 after 24 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ranfac Single Action Biopsy Needle: named in the summary without a submission number
- (no number) Ranfac Goldenberg Bone Marrow Biopsy Needle: named in the summary without a submission number
- (no number) Ethicon Endo-Surgery Inc. Mammotome Hand Held 11 Gauge Biopsy Probe: named in the summary without a submission number

## Most influential descendants
- K121181: Swannshidi Bone Marrow Aspiration Needle (2012), 6 descendants of its own
- K140991: Ranfac Aspiration Needle with Adjustable Guide (2014), 5 descendants of its own
- K150563: Marrow Cellution Bone Marrow Aspiration Needle (2015), 4 descendants of its own
- K223612: Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) (2023), 1 descendant of its own
- K202287: Ran-Flex-B Bone Marrow Aspiration Needle (2020), 1 descendant of its own

## Indications for use
The GSS Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy

Source page: https://510kreport.com/device/K031344
Methodology: https://510kreport.com/methodology