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FDA 510(k)

GENYX FLEXIBLE INJECTION NEEEDLE

K-Number: K001146 · 2000-06-30

ApplicantGeny Medical, Inc.
Decision Date2000-06-30
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GENYX FLEXIBLE INJECTION NEEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Geny Medical, Inc.. It received FDA 510(k) clearance on 2000-06-30 under 510(k) number K001146. 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 GENYX FLEXIBLE INJECTION NEEEDLE?

GENYX FLEXIBLE INJECTION NEEEDLE is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Geny Medical, Inc.. The 510(k) number is K001146.

When did GENYX FLEXIBLE INJECTION NEEEDLE receive FDA 510(k) clearance?

GENYX FLEXIBLE INJECTION NEEEDLE received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001146.

Who is the listed applicant for GENYX FLEXIBLE INJECTION NEEEDLE?

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

What is the FDA product code for GENYX FLEXIBLE INJECTION NEEEDLE?

The FDA product code for GENYX FLEXIBLE INJECTION NEEEDLE 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 Geny Medical, 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.

K792561MINI-H-FIXATION

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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