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FDA 510(k)

SANARUS INDICA MARKER SYSTEM

K-Number: K020054 · 2002-10-16

ApplicantSanarus Medical, Inc.
Decision Date2002-10-16
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SANARUS INDICA MARKER 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 2002-10-16 under 510(k) number K020054. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANARUS INDICA MARKER SYSTEM?

SANARUS INDICA MARKER SYSTEM is a medical device that received FDA 510(k) clearance on 2002-10-16. The listed applicant is Sanarus Medical, Inc.. The 510(k) number is K020054.

When did SANARUS INDICA MARKER SYSTEM receive FDA 510(k) clearance?

SANARUS INDICA MARKER SYSTEM received FDA 510(k) clearance on 2002-10-16, under 510(k) number K020054.

Who is the listed applicant for SANARUS INDICA MARKER 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 INDICA MARKER SYSTEM?

The FDA product code for SANARUS INDICA MARKER SYSTEM is FZP.

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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, VD0600K061510SANARUS VISICA TREATMENT SYSTEMK052861MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000K051581SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000

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Related Devices (Code: FZP)

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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