FDA 510(k)

SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012

K-Number: K080171 · 2008-03-06

Decision Date2008-03-06

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 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 2008-03-06 under 510(k) number K080171. 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 INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012?

SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 is a medical device that received FDA 510(k) clearance on 2008-03-06. The listed applicant is Sanarus Medical, Inc.. The 510(k) number is K080171.

When did SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 receive FDA 510(k) clearance?

SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 received FDA 510(k) clearance on 2008-03-06, under 510(k) number K080171.

Who is the listed applicant for SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012?

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 INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012?

The FDA product code for SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 is KNW.

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Other records listing Sanarus Medical, Inc. as applicant

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 K042136SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM

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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.