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FDA 510(k)

HP-ONE

K-Number: K012411 · 2001-09-25

ApplicantGi Supply
Decision Date2001-09-25
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HP-ONE is the device name listed in this FDA 510(k) record. The listed applicant is Gi Supply. It received FDA 510(k) clearance on 2001-09-25 under 510(k) number K012411. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HP-ONE?

HP-ONE is a medical device that received FDA 510(k) clearance on 2001-09-25. The listed applicant is Gi Supply. The 510(k) number is K012411.

When did HP-ONE receive FDA 510(k) clearance?

HP-ONE received FDA 510(k) clearance on 2001-09-25, under 510(k) number K012411.

Who is the listed applicant for HP-ONE?

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

What is the FDA product code for HP-ONE?

The FDA product code for HP-ONE is LYR.

Other records listing Gi Supply 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.

K191923EverLift Submucosal Lifting AgentK031360GI SUPPLY BILIARY STENTK970187RUNYON LARGE VOLUME PARACENTESIS KITK970186GI SUPPLY PARACENTESIS PUMPK944903HP-FASTK931044OXY-BLOC

View all 8 devices →

Related Devices (Code: LYR)

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.

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.

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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