FDA 510(k)

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

N.º K: K200320 · 2021-02-05

SolicitanteM/s. Meril Endo Surgery Private Limited.

Fecha de decisión2021-02-05

Código de productoGDW

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload is the device name listed in this FDA 510(k) record. The listed applicant is M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K200320. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload?

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K200320.

When did Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload receive FDA 510(k) clearance?

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload received FDA 510(k) clearance on 2021-02-05, under 510(k) number K200320.

Who is the listed applicant for Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload?

The FDA 510(k) record lists M/s. Meril Endo Surgery Private Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload?

The FDA product code for Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload is GDW.

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 M/s. Meril Endo Surgery Private Limited. como solicitante

K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture K233386Monik™ - Disposable Endoscopic Trocar K2322461) PINION™ Sutura PDO Sin Nudo - Sutura Absorbible de Polí (P-Dioxanona) Sin Nudo; 2) PINION™ Sutura PGA-PCL Sin Nudo - Sutura Absorbible de Ácido Poliglicólico - Polí (Glicolida-Co-Caprolactona) Sin Nudo K230981Meriglu Topical Skin Adhesive K200452Meril-Bonewax K200166Mirus Ligating Clip, Mirus Ligating Clip Applier

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: GDW)

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.