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FDA 510(k)

CLARUS MODEL 5197 SIGHTLITE

K-Number: K971455 · 1997-05-20

ApplicantClarus Medical Systems, Inc.
Decision Date1997-05-20
Product CodeFTI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLARUS MODEL 5197 SIGHTLITE 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 1997-05-20 under 510(k) number K971455. The device is classified under product code FTI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARUS MODEL 5197 SIGHTLITE?

CLARUS MODEL 5197 SIGHTLITE is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is Clarus Medical Systems, Inc.. The 510(k) number is K971455.

When did CLARUS MODEL 5197 SIGHTLITE receive FDA 510(k) clearance?

CLARUS MODEL 5197 SIGHTLITE received FDA 510(k) clearance on 1997-05-20, under 510(k) number K971455.

Who is the listed applicant for CLARUS MODEL 5197 SIGHTLITE?

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 MODEL 5197 SIGHTLITE?

The FDA product code for CLARUS MODEL 5197 SIGHTLITE is FTI.

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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)K960915CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXXK962255CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)K955598CLARUS SPINEPEN MODEL 2126

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Related Devices (Code: FTI)

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.

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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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