Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DemeTECH DemeFORCE Nonabsorbable Surgical Suture

K-Number: K190777 · 2019-07-31

ApplicantDemetech Corporation
Decision Date2019-07-31
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DemeTECH DemeFORCE Nonabsorbable Surgical Suture is a medical device manufactured by Demetech Corporation. It received FDA 510(k) clearance on 2019-07-31 under approval number K190777. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DemeTECH DemeFORCE Nonabsorbable Surgical Suture?

DemeTECH DemeFORCE Nonabsorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2019-07-31. It is manufactured by Demetech Corporation. The 510(k) number is K190777.

When was DemeTECH DemeFORCE Nonabsorbable Surgical Suture approved by the FDA?

DemeTECH DemeFORCE Nonabsorbable Surgical Suture received FDA 510(k) clearance on 2019-07-31, under approval number K190777.

What company makes DemeTECH DemeFORCE Nonabsorbable Surgical Suture?

DemeTECH DemeFORCE Nonabsorbable Surgical Suture is manufactured by Demetech Corporation.

What is the FDA product code for DemeTECH DemeFORCE Nonabsorbable Surgical Suture?

The FDA product code for DemeTECH DemeFORCE Nonabsorbable Surgical Suture is GAT.

Related Clinical Trials

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 NCT05261425 Suture Closure Trial COMPLETED NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT07498361 Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial. RECRUITING NCT06636136 Transtibial Osseointegration RECRUITING

Other Devices by Demetech Corporation

K181578DemeTECH PTFE Nonabsorbable Surgical Suture K181582DemeTECH DemeDIOX absorbable surgical suture K191361DemeDIOX Barbed Absorbable Surgical Suture K201479DemeMASK

Related Devices (Code: GAT)

K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp. K162247PERMATAPEMedos International SARL K162310XBraid TT Suture TapeStryker K161638SPEEDTRAP Graft Preparation SystemMedos International SARL K153089'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc. K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse CurvedIvy Sports Medicine, LLC

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.

↑