Home / 510(k) Clearances / K192349

510(k) K192349

Bactisure Wound Lavage by Next Science, LLC — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2020
Date Received
August 29, 2019
Clearance Type
Traditional
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 Next Science, LLC

  • K203446 — TorrentX Wound Wash (September 23, 2021)
  • K203835 — MIS Solution (April 23, 2021)
  • K163188 — Next Science Wound Gel (Rx) (March 6, 2017)
  • K161165 — Next Science Irrigation Solution (September 7, 2016)
  • K150792 — Next Science Wound Gel (December 17, 2015)

Other clearances for product code FQH

  • K253996 — BD Surgiphor™ Antimicrobial Irrigation System (910110) (February 25, 2026)
  • 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)