FDA 510(k)

CRYLREX

K-Number: K161629 · 2017-02-10

Decision Date2017-02-10

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CRYLREX is a medical device manufactured by Sm Eng Co., Ltd.. It received FDA 510(k) clearance on 2017-02-10 under approval number K161629. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYLREX?

CRYLREX is a medical device that received FDA 510(k) clearance on 2017-02-10. It is manufactured by Sm Eng Co., Ltd.. The 510(k) number is K161629.

When was CRYLREX approved by the FDA?

CRYLREX received FDA 510(k) clearance on 2017-02-10, under approval number K161629.

What company makes CRYLREX?

CRYLREX is manufactured by Sm Eng Co., Ltd..

What is the FDA product code for CRYLREX?

The FDA product code for CRYLREX is GAM.

Other Devices by Sm Eng Co., Ltd.

K161633REXLON, REXSIL K173747REXLENE K173779REXMONO, PDREX K200392REXSIN

Related Devices (Code: GAM)

K160564TroClose1200Gordian Surgical, Ltd. K161726E-Pack Procedure KitETHICON, Inc. K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing DeviceEthicon, LLC K173043Holycon Synthetic Absorbable SuturesNantong Holycon Medical Devices Co., Ltd. K171001Monosyn Quick Synthetic Absorbable Surgical SutureAesculap, Inc. K170166CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical SutureCpt Sutures Co., Ltd.

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.