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FDA 510(k)

CLARUS SERIES 2100 ENDOSCOPE

K-Number: K923514 · 1994-01-07

ApplicantClarus Medical Systems, Inc.
Decision Date1994-01-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLARUS SERIES 2100 ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K923514. 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 CLARUS SERIES 2100 ENDOSCOPE?

CLARUS SERIES 2100 ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Clarus Medical Systems, Inc.. The 510(k) number is K923514.

When did CLARUS SERIES 2100 ENDOSCOPE receive FDA 510(k) clearance?

CLARUS SERIES 2100 ENDOSCOPE received FDA 510(k) clearance on 1994-01-07, under 510(k) number K923514.

Who is the listed applicant for CLARUS SERIES 2100 ENDOSCOPE?

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

What is the FDA product code for CLARUS SERIES 2100 ENDOSCOPE?

The FDA product code for CLARUS SERIES 2100 ENDOSCOPE is HRX.

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Other records listing Clarus Medical Systems, 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.

K980588CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000K974579PERCSCOPE MODEL 2600K971584CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)K971455CLARUS MODEL 5197 SIGHTLITEK960915CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXXK962255CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)

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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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