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FDA 510(k)

AED RESECTOSCOPE

K-Number: K102663 · 2010-12-30

ApplicantNational Advanced Endoscopy Devices, Inc.
Decision Date2010-12-30
Product CodeFJL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AED RESECTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is National Advanced Endoscopy Devices, Inc.. It received FDA 510(k) clearance on 2010-12-30 under 510(k) number K102663. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AED RESECTOSCOPE?

AED RESECTOSCOPE is a medical device that received FDA 510(k) clearance on 2010-12-30. The listed applicant is National Advanced Endoscopy Devices, Inc.. The 510(k) number is K102663.

When did AED RESECTOSCOPE receive FDA 510(k) clearance?

AED RESECTOSCOPE received FDA 510(k) clearance on 2010-12-30, under 510(k) number K102663.

Who is the listed applicant for AED RESECTOSCOPE?

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

What is the FDA product code for AED RESECTOSCOPE?

The FDA product code for AED RESECTOSCOPE is FJL.

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Other records listing National Advanced Endoscopy Devices, 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.

K170285AED SinuscopeK081553AED BIPOLAR FORCEPS, MODEL 13-1646K081503AED MONOPOLAR LAP ACCESSORIESK993689AED CYSTOSCOPEK993688AED LAPAROSCOPEK991656AED ARTHROSCOPE

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Related Devices (Code: FJL)

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.

K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KGK221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.K230205Veloxion SystemCorinth Medtech, Inc.K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc.K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue CatchCorinth Medtech, Inc.K162979Veloxion SystemCorinth Medtech, Inc.

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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