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510(k) K253996

BD Surgiphor™ Antimicrobial Irrigation System (910110) by Becton, Dickinson and Company (BD) — Product Code FQH

K253996 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company (BD) for the device "BD Surgiphor™ Antimicrobial Irrigation System (910110)". The FDA issued a decision of Substantially Equivalent on February 25, 2026. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Becton, Dickinson and Company (BD) has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2026
Date Received
December 12, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type

Other clearances by Becton, Dickinson and Company (BD)

  • K112586 — CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) (October 18, 2011)
  • K111366 — BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM (September 30, 2011)
  • K110105 — BD PEN NEEDLE (April 28, 2011)
  • K091292 — BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 (August 25, 2009)

Other clearances for product code FQH

  • K253445 — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (February 20, 2026)
  • K231023 — ERBEJET® 2 System (June 15, 2023)
  • K220759 — Armis VeriCyn Wound Wash (May 25, 2023)
  • K220964 — VERSAJET Hydrosurgery System (III) (May 16, 2023)
  • K221504 — BD Surgiphor™ Antimicrobial Irrigation System (October 14, 2022)
  • K222804 — Irrisept Antimicrobial Wound Lavage (September 22, 2022)
  • K210987 — IRRIGO Wound Wash Jet System (May 31, 2022)
  • K213616 — BD Surgiphor Antimicrobial Irrigation System (March 23, 2022)
  • K210536 — Irrisept Antimicrobial Wound Lavage (May 28, 2021)
  • K202222 — Irrisept Wound Debridement and Cleansing System (December 14, 2020)

FDA data resources