FDA 510(k)

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

N.º K: K192144 · 2020-03-25

Fecha de decisión2020-03-25

Código de productoNEW

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K192144. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device?

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is ETHICON, Inc.. The 510(k) number is K192144.

When did STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device receive FDA 510(k) clearance?

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device received FDA 510(k) clearance on 2020-03-25, under 510(k) number K192144.

Who is the listed applicant for STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device?

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 Spiral PDS Plus Bidirectional Knotless Tissue Control Device?

The FDA product code for STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device is NEW.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a ETHICON, Inc. como solicitante

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices 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

Ver todos los 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.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.