NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR— 510(k) K120468

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K120468 for NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR, Substantially Equivalent on 2012-07-06. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2012-02-16
Decision date: 2012-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.