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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, manipulator/injector, uterine
Product CodeLKF
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE
  SUBSTANTIALLY EQUIVALENT 1
CATHETER RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEARPATH SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
COOPER SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
CROSSBAY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCONTROL
  SUBSTANTIALLY EQUIVALENT 1
FEMASYS INC.
  SUBSTANTIALLY EQUIVALENT 5
GYNETECH PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 2
KRONNER PROTOTYPES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OBG PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
REJONI, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERLING MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
THE O R COMPANY PTY LTD
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 45 45
2015 53 53
2016 62 62
2017 64 64
2018 15 15

Recalls
Manufacturer Recall Class Date Posted
1 Clinical Innovations, LLC II May-26-2020
2 Cooper Surgical, Inc. II Nov-26-2012
3 CooperSurgical, Inc. II Dec-06-2023
4 CooperSurgical, Inc. II Jun-08-2015
5 CooperSurgical, Inc. II Sep-05-2014
6 CooperSurgical, Inc. II Jun-11-2014
7 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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