BD Surgiphor Antimicrobial Irrigation System (910110)— 510(k) K253996

Name: FDA 510(k) clearance K253996
Creator: U.S. Food and Drug Administration
Published: 2026-02-25

Substantially Equivalent

Becton, Dickinson and Company (BD)

FDA 510(k) clearance K253996 for BD Surgiphor Antimicrobial Irrigation System (910110), Substantially Equivalent on 2026-02-25. Applicant: Becton, Dickinson and Company (BD). Device class: 2.

Clearance details

Applicant: Becton, Dickinson and Company (BD)
Product code: Code FQH
Device class: Class 2
Regulation: 21 CFR 880.5475
Advisory panel: General Hospital
Date received: 2025-12-12
Decision date: 2026-02-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.