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FDA 510(k)

N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110

K-Number: K043383 · 2005-10-27

ApplicantPhysion, Inc.
Decision Date2005-10-27
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 is the device name listed in this FDA 510(k) record. The listed applicant is Physion, Inc.. It received FDA 510(k) clearance on 2005-10-27 under 510(k) number K043383. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110?

N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 is a medical device that received FDA 510(k) clearance on 2005-10-27. The listed applicant is Physion, Inc.. The 510(k) number is K043383.

When did N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 receive FDA 510(k) clearance?

N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 received FDA 510(k) clearance on 2005-10-27, under 510(k) number K043383.

Who is the listed applicant for N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110?

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

What is the FDA product code for N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110?

The FDA product code for N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 is FBK.

Related Clinical Trials

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.

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Other records listing Physion, Inc. 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.

K022950MINIPHYSIONIZER 2.0 AND ELECTRODES

Related Devices (Code: FBK)

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.

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

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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