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FDA 510(k)

TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE

K-Number: K901437 · 1990-06-18

ApplicantTelemed Systems, Inc.
Decision Date1990-06-18
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Telemed Systems, Inc.. It received FDA 510(k) clearance on 1990-06-18 under 510(k) number K901437. 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 SCLEROTHERAPHY NEEDLE?

TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE is a medical device that received FDA 510(k) clearance on 1990-06-18. The listed applicant is Telemed Systems, Inc.. The 510(k) number is K901437.

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

TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE received FDA 510(k) clearance on 1990-06-18, under 510(k) number K901437.

Who is the listed applicant for TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE?

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

What is the FDA product code for TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE?

The FDA product code for TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE is FBK.

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Other records listing Telemed Systems, 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.

K020379PPD BALLOON DILATATION CATHETERK013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOONK010412FLEXIBLE ENDOSCOPIC SCISSORSK9924025.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCHK992390HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATDK974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR

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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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