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FDA 510(k)

XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01

K-Number: K091432 · 2009-06-12

ApplicantAnulex Technologies, Inc.
Decision Date2009-06-12
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 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 2009-06-12 under 510(k) number K091432. 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 XC-200-01?

XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 is a medical device that received FDA 510(k) clearance on 2009-06-12. The listed applicant is Anulex Technologies, Inc.. The 510(k) number is K091432.

When did XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 receive FDA 510(k) clearance?

XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 received FDA 510(k) clearance on 2009-06-12, under 510(k) number K091432.

Who is the listed applicant for XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01?

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 XC-200-01?

The FDA product code for XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 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.

K121354MICRO/MINI N-PK(F) BONE ANCHORK121356MICRO/MINI N-PK(H) BONE ANCHORK113805FIXATE TISSUE BANDK113400FIXATE TISSUE BANDK112849FIXATE TISSUE BANDK111462FIXATE TISSUE BAND

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Related Devices (Code: GAT)

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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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