FDA 510(k)

PIGALILEO 4TH GENERATION SYSTEM

K-Number: K080875 · 2008-07-18

Decision Date2008-07-18

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PIGALILEO 4TH GENERATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2008-07-18 under 510(k) number K080875. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIGALILEO 4TH GENERATION SYSTEM?

PIGALILEO 4TH GENERATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K080875.

When did PIGALILEO 4TH GENERATION SYSTEM receive FDA 510(k) clearance?

PIGALILEO 4TH GENERATION SYSTEM received FDA 510(k) clearance on 2008-07-18, under 510(k) number K080875.

Who is the listed applicant for PIGALILEO 4TH GENERATION SYSTEM?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIGALILEO 4TH GENERATION SYSTEM?

The FDA product code for PIGALILEO 4TH GENERATION SYSTEM is HAW.

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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.