ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00— 510(k) K082114

Substantially Equivalent

Apollo Endosurgery, Inc.

FDA 510(k) clearance K082114 for ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00, Substantially Equivalent on 2008-12-19. Applicant: Apollo Endosurgery, Inc..

Clearance details

Applicant: Apollo Endosurgery, Inc.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2008-07-28
Decision date: 2008-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.