BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)— 510(k) K253445

Substantially Equivalent

FDA 510(k) clearance K253445 for BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120), Substantially Equivalent on 2026-02-20. Applicant: Bd.

Clearance details

Applicant: Bd
Product code: Code FQH
Advisory panel: General Hospital
Date received: 2025-10-02
Decision date: 2026-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

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.