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FDA 510(k)

BD Surgiphor™ Antimicrobial Irrigation System

K-Number: K221504 · 2022-10-14

ApplicantBd
Decision Date2022-10-14
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Surgiphor™ Antimicrobial Irrigation System is the device name listed in this FDA 510(k) record. The listed applicant is Bd. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K221504. 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 BD Surgiphor™ Antimicrobial Irrigation System?

BD Surgiphor™ Antimicrobial Irrigation System is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Bd. The 510(k) number is K221504.

When did BD Surgiphor™ Antimicrobial Irrigation System receive FDA 510(k) clearance?

BD Surgiphor™ Antimicrobial Irrigation System received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221504.

Who is the listed applicant for BD Surgiphor™ Antimicrobial Irrigation System?

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

What is the FDA product code for BD Surgiphor™ Antimicrobial Irrigation System?

The FDA product code for BD Surgiphor™ Antimicrobial Irrigation System is FQH.

Other records listing Bd as applicant

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.

K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitK180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

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 LimitedK222804Irrisept Antimicrobial Wound LavageIrrimax Corporation

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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