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FDA 510(k)

DemeTECH PTFE Nonabsorbable Surgical Suture

K-Number: K181578 · 2018-10-11

ApplicantDemetech Corporation
Decision Date2018-10-11
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DemeTECH PTFE Nonabsorbable Surgical Suture is a medical device manufactured by Demetech Corporation. It received FDA 510(k) clearance on 2018-10-11 under approval number K181578. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DemeTECH PTFE Nonabsorbable Surgical Suture?

DemeTECH PTFE Nonabsorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2018-10-11. It is manufactured by Demetech Corporation. The 510(k) number is K181578.

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

DemeTECH PTFE Nonabsorbable Surgical Suture received FDA 510(k) clearance on 2018-10-11, under approval number K181578.

What company makes DemeTECH PTFE Nonabsorbable Surgical Suture?

DemeTECH PTFE Nonabsorbable Surgical Suture is manufactured by Demetech Corporation.

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

The FDA product code for DemeTECH PTFE Nonabsorbable Surgical Suture is NBY.

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

K181582DemeTECH DemeDIOX absorbable surgical suture K191361DemeDIOX Barbed Absorbable Surgical Suture K190777DemeTECH DemeFORCE Nonabsorbable Surgical Suture K201479DemeMASK

Related Devices (Code: NBY)

K160744LOOK PTFE SutureSurgical Specialties Corporation K170842WEGO-PTFEFoosin Medical Supplies Inc., Ltd. K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures K163639LS-5 ePTFE SutureLsi Solutions K180630PTFE SURGICAL SUTUREOmnia Spa K173922C-PTFETM Surgical SutureCp Medical, Inc.

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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