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

Staple, Implantable

M/s. Meril Endo Surgery Private Limited

The following data is part of a premarket notification filed by M/s. Meril Endo Surgery Private Limited with the FDA for Mirus Circular Stapler, Mirus Linear Cutter And Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler And Reload.

Pre-market Notification Details

Device IDK200320
510k NumberK200320
Device Name:Mirus Circular Stapler, Mirus Linear Cutter And Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler And Reload
ClassificationStaple, Implantable
Applicant M/s. Meril Endo Surgery Private Limited Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg Chala, Vapi,  IN 396191
ContactUmesh Sharma
CorrespondentUmesh Sharma
M/s. Meril Endo Surgery Private Limited Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg Chala, Vapi,  IN 396191
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-07
Decision Date2021-02-05

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