# K120468: Ncircle (R) Nitinol Tipless Stone Extractor Ngage (R) Nitinol Stone Extractor

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 6, 2012 after 141 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K012527 (2001). 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)
- K012527: Ksea Sialoendoscopes and Accessories, KARL STORZ Endoscopy-America, Inc. (2001) Summary page 2.
- (no number) NCircle Tipless Stone Extractor: named in the summary without a submission number
- (no number) NGage Nitinol Stone Extractor: named in the summary without a submission number

## Indications for use
The NCircle Nitinol Tipless Stone Extractor is intended for the manipulation, entrapment, and extraction of calculi and other foreign bodies in the salivary ducts, and to minimize migration during intracorporeal lithotripsy and/or other interventional procedures. The NGage Nitinol Stone Extractor is intended for the manipulation, entrapment, and extraction of calculi and other foreign bodies in the salivary ducts, and to minimize migration during intracorporeal. lithotripsy and/or other interventional procedures.

Source page: https://510kreport.com/device/K120468
Methodology: https://510kreport.com/methodology