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FDA 510(k)

SURGIPHOR Wound Irrigation System

K-Number: K202071 · 2020-10-23

ApplicantOrthophor, LLC
Decision Date2020-10-23
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGIPHOR Wound Irrigation System is the device name listed in this FDA 510(k) record. The listed applicant is Orthophor, LLC. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K202071. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIPHOR Wound Irrigation System?

SURGIPHOR Wound Irrigation System is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Orthophor, LLC. The 510(k) number is K202071.

When did SURGIPHOR Wound Irrigation System receive FDA 510(k) clearance?

SURGIPHOR Wound Irrigation System received FDA 510(k) clearance on 2020-10-23, under 510(k) number K202071.

Who is the listed applicant for SURGIPHOR Wound Irrigation System?

The FDA 510(k) record lists Orthophor, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIPHOR Wound Irrigation System?

The FDA product code for SURGIPHOR Wound Irrigation System is FQH.

Related Devices (Code: FQH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)BdK231023ERBEJET® 2 SystemErbe Elektromedizin GmbHK220759Armis VeriCyn Wound WashArmis Biopharma, Inc.K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical LimitedK221504BD Surgiphor™ Antimicrobial Irrigation SystemBd

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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