FDA 510(k)

SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM

K-Number: K032506 · 2003-10-09

Decision Date2003-10-09

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SANARUS CENTRICA II ROTATIONAL CORE BIOPSY 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 2003-10-09 under 510(k) number K032506. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM?

SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Sanarus Medical, Inc.. The 510(k) number is K032506.

When did SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM receive FDA 510(k) clearance?

SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM received FDA 510(k) clearance on 2003-10-09, under 510(k) number K032506.

Who is the listed applicant for SANARUS CENTRICA II ROTATIONAL CORE BIOPSY 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 CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM?

The FDA product code for SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM is KNW.

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Other records listing Sanarus Medical, Inc. as applicant

K080171SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 K073533SANARUS V2 TREATMENT SYSTEM K062896V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 K061510SANARUS VISICA TREATMENT SYSTEM K052861MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 K051581SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.