Insufflation Retention Device— 510(k) K213773

Substantially Equivalent

Bpendo, LLC

FDA 510(k) clearance K213773 for Insufflation Retention Device, Substantially Equivalent on 2022-07-21. Applicant: Bpendo, LLC.

Clearance details

Applicant: Bpendo, LLC
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2021-12-02
Decision date: 2022-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norman, OK, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.