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FDA 510(k)

ENDO-LEADER

K-Number: K954641 · 1995-12-28

ApplicantMicrosurge, Inc.
Decision Date1995-12-28
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO-LEADER is the device name listed in this FDA 510(k) record. The listed applicant is Microsurge, Inc.. It received FDA 510(k) clearance on 1995-12-28 under 510(k) number K954641. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-LEADER?

ENDO-LEADER is a medical device that received FDA 510(k) clearance on 1995-12-28. The listed applicant is Microsurge, Inc.. The 510(k) number is K954641.

When did ENDO-LEADER receive FDA 510(k) clearance?

ENDO-LEADER received FDA 510(k) clearance on 1995-12-28, under 510(k) number K954641.

Who is the listed applicant for ENDO-LEADER?

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

What is the FDA product code for ENDO-LEADER?

The FDA product code for ENDO-LEADER is OCW.

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Other records listing Microsurge, Inc. as applicant

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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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