ClearanceBrief
Panels › Obstetrics/Gynecology › Product code LKF · Class 2

Cannula, Manipulator/Injector, Uterine

Regulation 884.4530

2510(k)s in 12 months (87 all time)
0recalls in 12 months (13 all time)
13recalls that name a 510(k)
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Top companies in LKF

Company510(k)sRecalls
CooperSurgical, Inc.46
Femasys, Inc.70
Ackrad Laboratories60
Catheter Research, Inc.41
Clinical Innovations, Inc.23
Cook Incorporated50
Panpac Medical Corporation40
A & A Medical, Inc.30
Conmed Corporation30
Zinnanti Surgical Instruments, Inc.30
DateFirm and productCodeLinked 510(k)
Dec 6, 2023CooperSurgical, Inc.
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology suc
Open, Classified		 LKFK013972
Dec 6, 2023CooperSurgical, Inc.
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhe
Open, Classified		 LKFK013972
Dec 6, 2023CooperSurgical, Inc.
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesio
Open, Classified		 LKFK961752
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
Open, Classified		 LKFK961752
May 30, 2019Clinical Innovations, LLC
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750*
Terminated		 LKFK131781
Jun 8, 2015CooperSurgical, Inc.
Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS
Terminated		 LKFK141523
Sep 5, 2014CooperSurgical, Inc.
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Terminated		 LKFK020951
Jun 11, 2014CooperSurgical, Inc.
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Terminated		 LKFK970492
Nov 26, 2012Cooper Surgical, Inc.
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where posi
Terminated		 LKFK932115
Nov 26, 2012Cooper Surgical, Inc.
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning
Terminated		 LKFK932115
Sep 2, 2008Clinical Innovations, LLC
ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
Terminated		 LKFK940681
Sep 2, 2008Clinical Innovations, LLC
ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
Terminated		 LKFK940681
Jun 1, 2006Catheter Research, Inc
Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid
Terminated		 LKFK020292

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