ERBELIFT HAND PUMP AND FLEXIBLE PROBE— 510(k) K092090

Name: FDA 510(k) clearance K092090
Creator: U.S. Food and Drug Administration
Published: 2009-11-30

Substantially Equivalent

Byrne Medical, Inc.

FDA 510(k) clearance K092090 for ERBELIFT HAND PUMP AND FLEXIBLE PROBE, Substantially Equivalent on 2009-11-30. Applicant: Byrne Medical, Inc.. Device class: 2.

Clearance details

Applicant: Byrne Medical, Inc.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-07-14
Decision date: 2009-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.