BD Surgiphor Antimicrobial Irrigation System (910110)— 510(k) K253996
Substantially EquivalentBecton, 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.
Summary
Becton, Dickinson and Company (BD) filed the BD Surgiphor Antimicrobial Irrigation System (910110) 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 Special 510(k), though the record lists General Hospital as the classification panel.
BD filed from Vernon Hills, Illinois. Review took 75 calendar days (December 12, 2025 to February 25, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Becton, Dickinson and Company (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
- Special
- Location
- Vernon Hills, IL, US
Recent devices under product code FQH
view allMore clearances from Becton, Dickinson and Company (BD)
view allAdverse 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.