Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Staple, Implantable
510(k) Number K192566
Device Name Reach and CQ'ENCE Circular Staplers
Applicant
Reach Surgical, Inc.
120 Xinxing Rd. W. Zone, Teda
Tianjin,  CN 300462
Applicant Contact Mark Goldin
Correspondent
Secqure Surgical
4480 Lake Forest Dr.
Cincinnati,  OH  45242
Correspondent Contact Rich Grant
Regulation Number878.4750
Classification Product Code
GDW  
Date Received09/18/2019
Decision Date 10/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-