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FDA 510(k)

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture

N.º K: K212380 · 2022-02-22

SolicitanteETHICON, Inc.
Fecha de decisión2022-02-22
Código de productoNEW
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K212380. 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 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture?

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is ETHICON, Inc.. The 510(k) number is K212380.

When did PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture receive FDA 510(k) clearance?

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture received FDA 510(k) clearance on 2022-02-22, under 510(k) number K212380.

Who is the listed applicant for PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture?

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 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture?

The FDA product code for PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture is NEW.

Ensayos clínicos relacionados

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Otros registros que enlistan a ETHICON, Inc. como solicitante

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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureK252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesK253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureK252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceK243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

Ver todos los 29 dispositivos →

Dispositivos relacionados (Código: NEW)

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.

K254238MINT MONO SuturesHans Biomed CorporationK253879MONOFIX PDOSamyang Holdings CorporationK261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed 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.

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