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510(k) K202071

SURGIPHOR Wound Irrigation System by Orthophor, LLC — Product Code FQH

K202071 is an FDA 510(k) premarket notification submitted by Orthophor, LLC for the device "SURGIPHOR Wound Irrigation System". The FDA issued a decision of Substantially Equivalent on October 23, 2020. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2020
Date Received
July 27, 2020
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 for product code FQH

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  • 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