JTECH 50 SERIES CUTTING LOOP— 510(k) K913587

Substantially Equivalent

J-Tech, Inc.

FDA 510(k) clearance K913587 for JTECH 50 SERIES CUTTING LOOP, Substantially Equivalent on 1991-10-23. Applicant: J-Tech, Inc..

Clearance details

Applicant: J-Tech, Inc.
Product code: Code FJL
Advisory panel: Gastroenterology, Urology
Date received: 1991-08-12
Decision date: 1991-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, UT, US

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Adverse events under product code FJL

product code FJL

Death: 2
Total: 2

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.