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FDA 510(k)

VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES

K-Number: K101734 · 2010-09-08

ApplicantVisionscope Technologies, LLC
Decision Date2010-09-08
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Visionscope Technologies, LLC. It received FDA 510(k) clearance on 2010-09-08 under 510(k) number K101734. 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 VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES?

VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES is a medical device that received FDA 510(k) clearance on 2010-09-08. The listed applicant is Visionscope Technologies, LLC. The 510(k) number is K101734.

When did VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES receive FDA 510(k) clearance?

VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES received FDA 510(k) clearance on 2010-09-08, under 510(k) number K101734.

Who is the listed applicant for VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES?

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

What is the FDA product code for VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES?

The FDA product code for VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES is HRX.

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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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