TUNNELER— 510(k) K943968

Substantially Equivalent

Denver Biomedicals, Inc.

FDA 510(k) clearance K943968 for TUNNELER, Substantially Equivalent on 1995-03-01. Applicant: Denver Biomedicals, Inc..

Clearance details

Applicant: Denver Biomedicals, Inc.
Product code: Code MDM
Advisory panel: General, Plastic Surgery
Date received: 1994-08-15
Decision date: 1995-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Evergreen, CO, US

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Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.