BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)— 510(k) K253445
Substantially EquivalentBd
FDA 510(k) clearance K253445 for BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120), Substantially Equivalent on 2026-02-20. Applicant: Bd. Device class: 2.
Summary
The applicant, listed as Bd, filed the BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) under product code FQH, jet lavage. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 880.5475. The General, Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists General Hospital as the classification panel.
The applicant filed from Vernon Hills, Illinois. FDA found it substantially equivalent 141 calendar days after receipt (October 2, 2025 to February 20, 2026).
Clearance details
- Applicant
- Bd
- Product code
- Product code FQH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5475
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
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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, through . 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.