STONE EXTRACTOR BALLOON CATHETER— 510(k) K011261

Substantially Equivalent

Medi-Globe Corp.

FDA 510(k) clearance K011261 for STONE EXTRACTOR BALLOON CATHETER, Substantially Equivalent on 2003-11-17. Applicant: Medi-Globe Corp..

Clearance details

Applicant: Medi-Globe Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2001-04-25
Decision date: 2003-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.