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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 a medical device manufactured by Orthophor, LLC. It received FDA 510(k) clearance on 2020-10-23 under approval 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. It is manufactured by Orthophor, LLC. The 510(k) number is K202071.

When was SURGIPHOR Wound Irrigation System approved by the FDA?

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

What company makes SURGIPHOR Wound Irrigation System?

SURGIPHOR Wound Irrigation System is manufactured by Orthophor, LLC.

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

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

Related Clinical Trials

NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT05729477 A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device TERMINATED NCT06149650 Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study RECRUITING

Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Related Devices (Code: FQH)

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Official Source

View on FDA Database →

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

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