NEOTRACT ANCHOR— 510(k) K061700

Substantially Equivalent

Neotract, Inc.

FDA 510(k) clearance K061700 for NEOTRACT ANCHOR, Substantially Equivalent on 2006-10-26. Applicant: Neotract, Inc..

Clearance details

Applicant: Neotract, Inc.
Product code: Code GAW
Advisory panel: General, Plastic Surgery
Date received: 2006-06-16
Decision date: 2006-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.