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FDA 510(k)

MODIFIED SPACEMAKER SYSTEM

K-Number: K042412 · 2004-09-24

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date2004-09-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED SPACEMAKER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 2004-09-24 under 510(k) number K042412. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SPACEMAKER SYSTEM?

MODIFIED SPACEMAKER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-24. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K042412.

When did MODIFIED SPACEMAKER SYSTEM receive FDA 510(k) clearance?

MODIFIED SPACEMAKER SYSTEM received FDA 510(k) clearance on 2004-09-24, under 510(k) number K042412.

Who is the listed applicant for MODIFIED SPACEMAKER SYSTEM?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED SPACEMAKER SYSTEM?

The FDA product code for MODIFIED SPACEMAKER SYSTEM is GCJ.

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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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