510(k) · Cleared
ClearedNcircle (R) Nitinol Tipless Stone Extractor Ngage (R) Nitinol Stone Extractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 6, 2012 as substantially equivalent to K012527 (KARL STORZ Endoscopy-America, Inc., 2001) after a 141-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 6, 2012
- Review
- 141 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012527 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK012527 Ksea Sialoendoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2001
- This deviceK120468 Ncircle (R) Nitinol Tipless Stone Extractor Ngage (R) Nitinol Stone…Cook Incorporated · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012527 | Ksea Sialoendoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | 2001 | — |
| 0 (this device) | K120468 | Ncircle (R) Nitinol Tipless Stone Extractor Ngage (R) Nitinol Stone Extractor | Cook Incorporated | 2012 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012527 | Ksea Sialoendoscopes and AccessoriesSummary page 2…Stone Extractor, NGage Nitinol Stone Extractor 15 February 20 12 3. Predicate Devices KSEA Sialoendoscopes and Accessories (Karl Storz; Endoscopy - America, hic., K012527) NCircle Tipless Stone Extractor (Cook Medical, Class 115 10(k) exempt under ProCode FEL) N~age Nitinol Stone Extractor (Cook Med… | 2001 |
| * | — | NCircle Tipless Stone Extractor Named without a submission number | |
| * | — | NGage Nitinol Stone Extractor Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K012527.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120468: Ncircle (R) Nitinol Tipless Stone Extractor Ngage (R) Nitinol Stone Extractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120468
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026