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510(k) K200320

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload by M/s. Meril Endo Surgery Private Limited. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2021
Date Received
February 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

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  • K172146 — MERISTEEL (February 1, 2018)
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  • K172659 — MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorba (September 28, 2017)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)

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