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510(k) K211197

Disposable Endoscopic Cutter Stapler and Cartridge by Changzhou Waston Medical Appliance Co., Ltd. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2023
Date Received
April 21, 2021
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

Other clearances by Changzhou Waston Medical Appliance Co., Ltd.

  • K151062 — WASTON Metallic Intramedullary Nail System (December 17, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)
  • K151057 — WASTON Metallic Bone Plate and Screw Systems (August 10, 2015)
  • K100386 — DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 (March 1, 2010)

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