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510(k) K161165

Next Science Irrigation Solution by Next Science, LLC — Product Code FQH

K161165 is an FDA 510(k) premarket notification submitted by Next Science, LLC for the device "Next Science Irrigation Solution". The FDA issued a decision of Substantially Equivalent on September 7, 2016. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Next Science, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2016
Date Received
April 25, 2016
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)
  • K192349 — Bactisure Wound Lavage (January 23, 2020)
  • K163188 — Next Science Wound Gel (Rx) (March 6, 2017)
  • 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)

FDA data resources