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FDA 510(k)

Monosyn Quick Synthetic Absorbable Surgical Suture

K-Number: K171001 · 2017-10-23

ApplicantAesculap, Inc.
Decision Date2017-10-23
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Monosyn Quick Synthetic Absorbable Surgical Suture is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2017-10-23 under approval number K171001. 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 Monosyn Quick Synthetic Absorbable Surgical Suture?

Monosyn Quick Synthetic Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Aesculap, Inc.. The 510(k) number is K171001.

When was Monosyn Quick Synthetic Absorbable Surgical Suture approved by the FDA?

Monosyn Quick Synthetic Absorbable Surgical Suture received FDA 510(k) clearance on 2017-10-23, under approval number K171001.

What company makes Monosyn Quick Synthetic Absorbable Surgical Suture?

Monosyn Quick Synthetic Absorbable Surgical Suture is manufactured by Aesculap, Inc..

What is the FDA product code for Monosyn Quick Synthetic Absorbable Surgical Suture?

The FDA product code for Monosyn Quick Synthetic Absorbable Surgical Suture is GAM.

Related Clinical Trials

NCT06511414 Effect of Duramesh™ on Hernia Formation After Ileostomy Closure ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07574086 Stratafix vs. PDS (Fascial Closure RCT) NOT_YET_RECRUITING NCT05538286 Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation RECRUITING NCT07568288 The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair. NOT_YET_RECRUITING NCT05261425 Suture Closure Trial COMPLETED

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Aesculap, 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. 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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