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FDA 510(k)

SPINE SCOPE, MODEL 2180

K-Number: K011454 · 2001-12-13

ApplicantClarus Medical, LLC
Decision Date2001-12-13
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINE SCOPE, MODEL 2180 is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical, LLC. It received FDA 510(k) clearance on 2001-12-13 under 510(k) number K011454. 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 SPINE SCOPE, MODEL 2180?

SPINE SCOPE, MODEL 2180 is a medical device that received FDA 510(k) clearance on 2001-12-13. The listed applicant is Clarus Medical, LLC. The 510(k) number is K011454.

When did SPINE SCOPE, MODEL 2180 receive FDA 510(k) clearance?

SPINE SCOPE, MODEL 2180 received FDA 510(k) clearance on 2001-12-13, under 510(k) number K011454.

Who is the listed applicant for SPINE SCOPE, MODEL 2180?

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

What is the FDA product code for SPINE SCOPE, MODEL 2180?

The FDA product code for SPINE SCOPE, MODEL 2180 is HRX.

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Other records listing Clarus Medical, LLC 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.

K252790Digital ClarusScope System and Digital NeuroPEN SystemK240535Digital ClarusScope System; Digital NeuroPEN SystemK223615Digital ClarusScope System, Digital NeuroPEN SystemK200925Clarus Peel-Away Introducer SheathK082038CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-VK040919NUCLEOTOME PROBE SET, MODEL 21200

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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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