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FDA 510(k)

FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES

K-Number: K992040 · 1999-08-06

ApplicantFiber Imaging Technologies, Inc.
Decision Date1999-08-06
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Fiber Imaging Technologies, Inc.. It received FDA 510(k) clearance on 1999-08-06 under 510(k) number K992040. 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 FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES?

FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1999-08-06. The listed applicant is Fiber Imaging Technologies, Inc.. The 510(k) number is K992040.

When did FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES receive FDA 510(k) clearance?

FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES received FDA 510(k) clearance on 1999-08-06, under 510(k) number K992040.

Who is the listed applicant for FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES?

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

What is the FDA product code for FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES?

The FDA product code for FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES is HRX.

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Other records listing Fiber Imaging Technologies, 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.

K993300COLDLIGHTSOURCE PL3000K992527URETERO-RENOSCOPEK992437SCHOELLY RIGID ENDOSCOPESK991560NASO-LARYNGO-PHARYNGOSCOPE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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