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FDA 510(k)

XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS

K-Number: K062307 · 2006-09-01

ApplicantAnulex Technologies, Inc.
Decision Date2006-09-01
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS 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 2006-09-01 under 510(k) number K062307. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS?

XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS is a medical device that received FDA 510(k) clearance on 2006-09-01. The listed applicant is Anulex Technologies, Inc.. The 510(k) number is K062307.

When did XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS receive FDA 510(k) clearance?

XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS received FDA 510(k) clearance on 2006-09-01, under 510(k) number K062307.

Who is the listed applicant for XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS?

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 XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS?

The FDA product code for XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS is GAT.

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Other records listing Anulex Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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