SURGIPHOR Wound Irrigation System— 510(k) K202071

Name: FDA 510(k) clearance K202071
Creator: U.S. Food and Drug Administration
Published: 2020-10-23

Substantially Equivalent

Orthophor, LLC

FDA 510(k) clearance K202071 for SURGIPHOR Wound Irrigation System, Substantially Equivalent on 2020-10-23. Applicant: Orthophor, LLC. Device class: 2.

Clearance details

Applicant: Orthophor, LLC
Product code: Code FQH
Device class: Class 2
Regulation: 21 CFR 880.5475
Advisory panel: General Hospital
Date received: 2020-07-27
Decision date: 2020-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FQH

view all

K253996 — BD Surgiphor Antimicrobial Irrigation System (910110)2026-02-25
K253445 — BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)2026-02-20
K231023 — ERBEJET® 2 System2023-06-15
K220759 — Armis VeriCyn Wound Wash2023-05-25
K220964 — VERSAJET Hydrosurgery System (III)2023-05-16

Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.