FDA 510(k)

REXLENE

K-Number: K173747 · 2018-12-21

Decision Date2018-12-21

Product CodeGAW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

REXLENE is the device name listed in this FDA 510(k) record. The listed applicant is Sm Eng Co., Ltd.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K173747. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REXLENE?

REXLENE is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Sm Eng Co., Ltd.. The 510(k) number is K173747.

When did REXLENE receive FDA 510(k) clearance?

REXLENE received FDA 510(k) clearance on 2018-12-21, under 510(k) number K173747.

Who is the listed applicant for REXLENE?

The FDA 510(k) record lists Sm Eng Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REXLENE?

The FDA product code for REXLENE is GAW.

Other records listing Sm Eng Co., Ltd. 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.

K200392REXSIN K173779REXMONO, PDREX K161633REXLON, REXSIL K161629CRYLREX

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.