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FDA 510(k)

TRANSENDOSCOPIC ASPIRATION NEEDLE

K-Number: K883093 · 1988-12-08

ApplicantEndovations
Decision Date1988-12-08
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANSENDOSCOPIC ASPIRATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Endovations. It received FDA 510(k) clearance on 1988-12-08 under 510(k) number K883093. 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 TRANSENDOSCOPIC ASPIRATION NEEDLE?

TRANSENDOSCOPIC ASPIRATION NEEDLE is a medical device that received FDA 510(k) clearance on 1988-12-08. The listed applicant is Endovations. The 510(k) number is K883093.

When did TRANSENDOSCOPIC ASPIRATION NEEDLE receive FDA 510(k) clearance?

TRANSENDOSCOPIC ASPIRATION NEEDLE received FDA 510(k) clearance on 1988-12-08, under 510(k) number K883093.

Who is the listed applicant for TRANSENDOSCOPIC ASPIRATION 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 TRANSENDOSCOPIC ASPIRATION NEEDLE?

The FDA product code for TRANSENDOSCOPIC ASPIRATION 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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