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FDA 510(k)

SANARUS VISICA TREATMENT SYSTEM

K-Number: K061510 · 2006-07-18

ApplicantSanarus Medical, Inc.
Decision Date2006-07-18
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SANARUS VISICA 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 2006-07-18 under 510(k) number K061510. 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 VISICA TREATMENT SYSTEM?

SANARUS VISICA TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-18. The listed applicant is Sanarus Medical, Inc.. The 510(k) number is K061510.

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

SANARUS VISICA TREATMENT SYSTEM received FDA 510(k) clearance on 2006-07-18, under 510(k) number K061510.

Who is the listed applicant for SANARUS VISICA 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 VISICA TREATMENT SYSTEM?

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

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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, CB3012K073533SANARUS V2 TREATMENT SYSTEMK062896V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600K052861MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000K051581SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000K042136SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM

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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.

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