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FDA 510(k)

WASHING/INJECTION NEEDLE

K-Number: K872060 · 1987-07-21

ApplicantEndovations
Decision Date1987-07-21
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WASHING/INJECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Endovations. It received FDA 510(k) clearance on 1987-07-21 under 510(k) number K872060. 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 WASHING/INJECTION NEEDLE?

WASHING/INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Endovations. The 510(k) number is K872060.

When did WASHING/INJECTION NEEDLE receive FDA 510(k) clearance?

WASHING/INJECTION NEEDLE received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872060.

Who is the listed applicant for WASHING/INJECTION NEEDLE?

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

What is the FDA product code for WASHING/INJECTION NEEDLE?

The FDA product code for WASHING/INJECTION NEEDLE is FBK.

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Other records listing Endovations 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.

K955413ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETERK942110INJECT-SNAREK934315ENDOVATIONS(R) .035 PRE-CUT PAPILLATOMEK9138412 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATHK9138705MM MICROSCISSORSK911155OVAL CUP BIOPSY FORCEP

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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

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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