FDA 510(k)

INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE

K-Number: K060413 · 2006-04-27

Decision Date2006-04-27

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE is the device name listed in this FDA 510(k) record. The listed applicant is Intact Medical Corporation. It received FDA 510(k) clearance on 2006-04-27 under 510(k) number K060413. 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 INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE?

INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE is a medical device that received FDA 510(k) clearance on 2006-04-27. The listed applicant is Intact Medical Corporation. The 510(k) number is K060413.

When did INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE receive FDA 510(k) clearance?

INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE received FDA 510(k) clearance on 2006-04-27, under 510(k) number K060413.

Who is the listed applicant for INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE?

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

What is the FDA product code for INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE?

The FDA product code for INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE is KNW.

Related Clinical Trials

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Other records listing Intact Medical Corporation as applicant

K152596Intact® Gen2 System K081057INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL

Related Devices (Code: KNW)

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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.