Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX

K-Number: K960915 · 1996-12-24

ApplicantClarus Medical Systems, Inc.
Decision Date1996-12-24
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX 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 1996-12-24 under 510(k) number K960915. 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 CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX?

CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX is a medical device that received FDA 510(k) clearance on 1996-12-24. The listed applicant is Clarus Medical Systems, Inc.. The 510(k) number is K960915.

When did CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX receive FDA 510(k) clearance?

CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX received FDA 510(k) clearance on 1996-12-24, under 510(k) number K960915.

Who is the listed applicant for CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX?

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 NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX?

The FDA product code for CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX is GWG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SIGHTLITEK962255CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)K955598CLARUS SPINEPEN MODEL 2126

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.

↑