EMBEDDING TOOL, MODEL TE-1000— 510(k) K060897

Substantially Equivalent

Medigroup, Inc.

FDA 510(k) clearance K060897 for EMBEDDING TOOL, MODEL TE-1000, Substantially Equivalent on 2006-07-18. Applicant: Medigroup, Inc..

Clearance details

Applicant: Medigroup, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 2006-04-03
Decision date: 2006-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oswego, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.