COMMUNITRACH TUBE— 510(k) K823291

Substantially Equivalent

Implant Technology, Inc.

FDA 510(k) clearance K823291 for COMMUNITRACH TUBE, Substantially Equivalent on 1983-01-08. Applicant: Implant Technology, Inc..

Clearance details

Applicant: Implant Technology, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1982-11-05
Decision date: 1983-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.