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FDA 510(k)

E-Pack Procedure Kit

K-Number: K161726 · 2016-07-12

ApplicantETHICON, Inc.
Decision Date2016-07-12
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

E-Pack Procedure Kit is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2016-07-12 under approval number K161726. 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 E-Pack Procedure Kit?

E-Pack Procedure Kit is a medical device that received FDA 510(k) clearance on 2016-07-12. It is manufactured by ETHICON, Inc.. The 510(k) number is K161726.

When was E-Pack Procedure Kit approved by the FDA?

E-Pack Procedure Kit received FDA 510(k) clearance on 2016-07-12, under approval number K161726.

What company makes E-Pack Procedure Kit?

E-Pack Procedure Kit is manufactured by ETHICON, Inc..

What is the FDA product code for E-Pack Procedure Kit?

The FDA product code for E-Pack Procedure Kit is GAM.

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Related Devices (Code: GAM)

K160564TroClose1200Gordian Surgical, Ltd. 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. K172659MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical SutureM/s. Meril Endo Surgery Private Limited.

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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