FDA 510(k)

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices

Número K: K252047 · 2026-05-18

Data da decisão2026-05-18

Código do produtoNEW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2026-05-18 under 510(k) number K252047. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices?

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is ETHICON, Inc.. The 510(k) number is K252047.

When did STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices receive FDA 510(k) clearance?

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices received FDA 510(k) clearance on 2026-05-18, under 510(k) number K252047.

Who is the listed applicant for STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices?

The FDA 510(k) record lists ETHICON, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices?

The FDA product code for STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices is NEW.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam ETHICON, Inc. como candidato(a)

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

Ver todos os 29 dispositivos →

Dispositivos Relacionados (Código: NEW)

K254238MINT MONO SuturesHans Biomed Corporation K253879MONOFIX PDOSamyang Holdings Corporation K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC K252171Barbed PDO SutureSutura Medical Technology, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.