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FDA 510(k)

INCLOSE SURGICAL MESH SYSTEM

K-Number: K050969 · 2005-08-18

ApplicantAnulex Technologies, Inc.
Decision Date2005-08-18
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INCLOSE SURGICAL MESH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Anulex Technologies, Inc.. It received FDA 510(k) clearance on 2005-08-18 under 510(k) number K050969. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCLOSE SURGICAL MESH SYSTEM?

INCLOSE SURGICAL MESH SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-18. The listed applicant is Anulex Technologies, Inc.. The 510(k) number is K050969.

When did INCLOSE SURGICAL MESH SYSTEM receive FDA 510(k) clearance?

INCLOSE SURGICAL MESH SYSTEM received FDA 510(k) clearance on 2005-08-18, under 510(k) number K050969.

Who is the listed applicant for INCLOSE SURGICAL MESH SYSTEM?

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

What is the FDA product code for INCLOSE SURGICAL MESH SYSTEM?

The FDA product code for INCLOSE SURGICAL MESH SYSTEM is FTL.

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Other records listing Anulex Technologies, Inc. as applicant

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Related Devices (Code: FTL)

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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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