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FDA 510(k)

CLARUS ENDOSCOPIC HOOK KNIFE

K-Number: K925741 · 1993-08-24

ApplicantClarus Medical Systems, Inc.
Decision Date1993-08-24
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CLARUS ENDOSCOPIC HOOK KNIFE 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 1993-08-24 under 510(k) number K925741. The device is classified under product code HLX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARUS ENDOSCOPIC HOOK KNIFE?

CLARUS ENDOSCOPIC HOOK KNIFE is a medical device that received FDA 510(k) clearance on 1993-08-24. The listed applicant is Clarus Medical Systems, Inc.. The 510(k) number is K925741.

When did CLARUS ENDOSCOPIC HOOK KNIFE receive FDA 510(k) clearance?

CLARUS ENDOSCOPIC HOOK KNIFE received FDA 510(k) clearance on 1993-08-24, under 510(k) number K925741.

Who is the listed applicant for CLARUS ENDOSCOPIC HOOK KNIFE?

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 ENDOSCOPIC HOOK KNIFE?

The FDA product code for CLARUS ENDOSCOPIC HOOK KNIFE is HLX.

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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: HLX)

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.

K003442MODIFICATION TO EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K983983EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K914393RETINA TESTERRetina TesterK914163SCOPTOPIC SENSITIVITY TEST-1[SST-1]Lkc Technologies, Inc.K873990IRAS EDS INTERFEROMETRIC STIMULATORRandwal Instrument Co., Inc.K853812PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)Biosan Laboratories, Inc.

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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