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)

SANARUS V2 TREATMENT SYSTEM

K-Number: K073533 · 2008-02-07

ApplicantSanarus Medical, Inc.
Decision Date2008-02-07
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SANARUS V2 TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sanarus Medical, Inc.. It received FDA 510(k) clearance on 2008-02-07 under 510(k) number K073533. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANARUS V2 TREATMENT SYSTEM?

SANARUS V2 TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-07. The listed applicant is Sanarus Medical, Inc.. The 510(k) number is K073533.

When did SANARUS V2 TREATMENT SYSTEM receive FDA 510(k) clearance?

SANARUS V2 TREATMENT SYSTEM received FDA 510(k) clearance on 2008-02-07, under 510(k) number K073533.

Who is the listed applicant for SANARUS V2 TREATMENT SYSTEM?

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

What is the FDA product code for SANARUS V2 TREATMENT SYSTEM?

The FDA product code for SANARUS V2 TREATMENT SYSTEM is GEH.

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 Sanarus Medical, 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.

K080171SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012K062896V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600K061510SANARUS VISICA TREATMENT SYSTEMK052861MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000K051581SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000K042136SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM

View all 14 devices →

Related Devices (Code: GEH)

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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

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.

↑