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FDA 510(k)

INSTRUMENT SCOPE

K-Number: K953685 · 1995-10-12

ApplicantClarus Medical Systems, Inc.
Decision Date1995-10-12
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INSTRUMENT SCOPE 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 1995-10-12 under 510(k) number K953685. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENT SCOPE?

INSTRUMENT SCOPE is a medical device that received FDA 510(k) clearance on 1995-10-12. The listed applicant is Clarus Medical Systems, Inc.. The 510(k) number is K953685.

When did INSTRUMENT SCOPE receive FDA 510(k) clearance?

INSTRUMENT SCOPE received FDA 510(k) clearance on 1995-10-12, under 510(k) number K953685.

Who is the listed applicant for INSTRUMENT SCOPE?

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 INSTRUMENT SCOPE?

The FDA product code for INSTRUMENT SCOPE is GWG.

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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)

View all 22 devices →

Related Devices (Code: GWG)

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.

K253602Precision S 4K SinuscopeStryker EndoscopyK253679Hydro Irrigation SystemStryker InstrumentsK243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences CorporationK233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

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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