FDA 510(k)

STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device

K-Number: K221744 · 2022-11-15

Decision Date2022-11-15

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2022-11-15 under approval number K221744. 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 STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device?

STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is a medical device that received FDA 510(k) clearance on 2022-11-15. It is manufactured by ETHICON, Inc.. The 510(k) number is K221744.

When was STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device approved by the FDA?

STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device received FDA 510(k) clearance on 2022-11-15, under approval number K221744.

What company makes STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device?

STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is manufactured by ETHICON, Inc..

What is the FDA product code for STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device?

The FDA product code for STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is GAM.

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Related PubMed Literature

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Other Devices by ETHICON, Inc.

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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

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