FDA 510(k)

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture

Número K: K212380 · 2022-02-22

Data da decisão2022-02-22

Código do produtoNEW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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

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

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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.

Fonte oficial

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