X-Tack Endoscopic HeliX Tacking System— 510(k) K201808

Substantially Equivalent

Apollo Endosurgery, Inc.

FDA 510(k) clearance K201808 for X-Tack Endoscopic HeliX Tacking System, Substantially Equivalent on 2020-12-15. Applicant: Apollo Endosurgery, Inc..

Clearance details

Applicant: Apollo Endosurgery, Inc.
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 2020-07-01
Decision date: 2020-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

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.