Insufflation Retention Device— 510(k) K213773

Name: FDA 510(k) clearance K213773
Creator: U.S. Food and Drug Administration
Published: 2022-07-21

Substantially Equivalent

Bpendo, LLC

FDA 510(k) clearance K213773 for Insufflation Retention Device, Substantially Equivalent on 2022-07-21. Applicant: Bpendo, LLC. Device class: 2.

Clearance details

Applicant: Bpendo, LLC
Product code: Code FDF
Device class: Class 2
Regulation: 21 CFR 876.1500
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 ↗

Recent devices under product code FDF

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K260503 — Triton 1 System2026-09-03
K261015 — Solo Scope Colonoscope System2026-08-21
K261587 — Insufflation Retention Device (IRD) (11173-325-101)2026-07-02
K260423 — Disposable Endoscopic Distal Attachments2026-05-28
K252457 — Disposable Distal End Tape Hood2026-01-30

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.