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FDA 510(k)

AED ARTHROSCOPE

K-Number: K991656 · 1999-12-02

ApplicantNational Advanced Endoscopy Devices, Inc.
Decision Date1999-12-02
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AED ARTHROSCOPE 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 1999-12-02 under 510(k) number K991656. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AED ARTHROSCOPE?

AED ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 1999-12-02. The listed applicant is National Advanced Endoscopy Devices, Inc.. The 510(k) number is K991656.

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

AED ARTHROSCOPE received FDA 510(k) clearance on 1999-12-02, under 510(k) number K991656.

Who is the listed applicant for AED ARTHROSCOPE?

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 ARTHROSCOPE?

The FDA product code for AED ARTHROSCOPE is HRX.

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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 SinuscopeK102663AED RESECTOSCOPEK081553AED BIPOLAR FORCEPS, MODEL 13-1646K081503AED MONOPOLAR LAP ACCESSORIESK993689AED CYSTOSCOPEK993688AED LAPAROSCOPE

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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