Cannula, Manipulator/Injector, Uterine
FDA product code LKF · Class II (moderate risk) · 21 CFR 884.4530 · Obstetrics/Gynecology
87510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Femasys, Inc. 7
- Ackrad Laboratories 6
- Cook, Inc. 5
- Catheter Research, Inc. 4
- Panpac Medical Corporation 4
- CooperSurgical, Inc. 4
- Zinnanti Surgical Instruments, Inc. 3
- A & A Medical, Inc. 3
- Conmed Corporation 3
- Clinical Innovations, LLC 2
- Conceptus, Inc. 2
- The O R Company Pty, Ltd. 2
- United States Surgical, A Division of Tyco Healthc 2
- Ovamed Corp. 2
- Utah Medical Products, Inc. 2
- Lyco Enterprises, Inc. 2
- Conmedcorp 2
- Cook Urological, Inc. 2
- Gynetech Pty. , Ltd. 2
- Li Medical Corporation , Ltd. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300)LKF · Traditional | Femasys, Inc. | 12/15/2025SE |
| K252260 | RELIEEV HSG Catheter (HSG7FA1)LKF · Traditional | Li Medical Corporation , Ltd. | 11/26/2025SE |
| K242002 | FemVue MINI Saline-Air DeviceLKF · Traditional | Femasys, Inc. | 11/22/2024SE |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0)LKF · Traditional | Li Medical Corporation , Ltd. | 10/16/2024SE |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250)LKF · Traditional | Femasys, Inc. | 09/06/2024SE |
| K222798 | Rejoni Intrauterine CatheterLKF · Traditional | Rejoni, Inc. | 12/16/2022SE |
| K223064 | ALLY II Uterine Positioning System (UPS)LKF · Special | CooperSurgical, Inc. | 10/28/2022SE |
| K220202 | Uterine ElevatOR PRO with OccludOR BalloonLKF · Traditional | The O R Company Pty, Ltd. | 03/31/2022SE |
| K212505 | DUMI ManipulatORLKF · Traditional | The O R Company Pty, Ltd. | 01/10/2022SE |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography CatheterLKF · Traditional | Cook Incorporated | 03/29/2019SE |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography CatheterLKF · Traditional | Cook Incorporated | 10/26/2018SE |
| K180291 | Cook Silicone Balloon HSG CatheterLKF · Traditional | Cook Incorporated | 10/26/2018SE |
| K172846 | Uterine ManipulatorLKF · Traditional | Beijing Hangtian Kadi Technology R&D Institute | 06/26/2018SE |
| K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set…LKF · Traditional | Cook Incorporated | 02/15/2018SE |
| K163214 | Unicare System, Unicare ManipulatorLKF · Traditional | Clearpath Surgical, Inc. | 02/07/2017SE |
| K160217 | uVue HSG/SHG CatheterLKF · Traditional | Cook Incorporated | 10/06/2016SE |
| K153092 | Ally Uterine Positioning SystemLKF · Special | CooperSurgical, Inc. | 12/21/2015SE |
| K150519 | ManipulatOR PRO, ManipulatORLKF · Traditional | Gynetech Pty. , Ltd. | 08/19/2015SE |
| K142545 | SonoFlow Sonohysterography and Sonohysterosalpingography DeviceLKF · Traditional | Crossbay Medical, Inc. | 03/20/2015SE |
| K143415 | Air Bubble Based Infuser (ABBI)LKF · Traditional | CooperSurgical, Inc. | 02/26/2015SE |
| K142716 | VcareLKF · Traditional | Conmed Corporation | 02/10/2015SE |
| K142164 | Manipulator; Manipulator ProLKF · Traditional | Gynetech Pty. , Ltd. | 12/17/2014SE |
| K141523 | Ally UpsLKF · Traditional | CooperSurgical, Inc. | 11/25/2014SE |
| K131781 | Clearview TotalLKF · Traditional | Clinical Innovations, LLC | 05/28/2014SE |
| K130758 | Kronner Side-Kick Uterine Manipulator HolderLKF · Traditional | Kronner Prototypes, Inc. | 12/11/2013SE |
| K122820 | Viky UpLKF · Traditional | Endocontrol | 06/18/2013SE |
| K123258 | The Advance Catheter for HSG and SisLKF · Special | Catheter Research, Inc. | 01/31/2013SE |
| K102898 | Bellota Sonohysterography Catheter with Cervical Cone, Bellota Sonohysterography…LKF · Traditional | Panpac Medical Corporation | 12/15/2011SE |
| K110993 | Femchec Pressure Managemet DeviceLKF · Traditional | Femasys, Inc. | 10/12/2011SE |
| K110288 | Femvue Saline-Air DeviceLKF · Traditional | Femasys, Inc. | 04/28/2011SE |
| K092983 | Panpac HSG Catheter SetLKF · Traditional | Panpac Medical Corporation | 06/07/2010SE |
| K092969 | H/S Catheter Set 5 French, Model 61-5005F, H/S Catheter Set 7 French, Model 61-5007FLKF · Traditional | Sterling Medical, Inc. | 04/30/2010SE |
| K100662 | Femvue Cornual Balloon CatheterLKF · Special | Femasys, Inc. | 04/07/2010SE |
| K092984 | Panpac Uterine Inector, Model UI-4.0, UI-2.0LKF · Traditional | Panpac Medical Corporation | 04/07/2010SE |
| K093556 | Vcare DXLKF · Traditional | Conmed Corporation | 03/12/2010SE |
| K092980 | Panpac Uterine Manipulator Injector, Model Umi 4.5LKF · Traditional | Panpac Medical Corporation | 03/11/2010SE |
| K083594 | Ez HSG Catheter.Foamseal CatheterLKF · Traditional | Obg Products | 07/21/2009SE |
| K083690 | Femvue(Tm) Catheter SystemLKF · Traditional | Femasys, Inc. | 06/23/2009SE |
| K071405 | Probe Holder SystemLKF · Traditional | Intuitive Surgical, Inc. | 10/09/2007SE |
| K071907 | Vcare Retractor/ElevatorLKF · Special | Conmed Corporation | 10/05/2007SE |
| K063611 | Saline/ Contrast Media Infusion CatheterLKF · Traditional | Utah Medical Products, Inc. | 05/23/2007SE |
| K061679 | Wallace Artificial Insemination CatheterLKF · Traditional | Irvine Scientific Sales Co., Inc. | 10/13/2006SE |
| K041062 | Intrauterine Venogram Needle SetLKF · Traditional | Cook Urological, Inc. | 10/01/2004SE |
| K040238 | Softseal HSG CatheterLKF · Traditional | Modern Medical Equipment Mfg., Ltd. | 06/22/2004SE |
| K041094 | HSG Catheter SetLKF · Traditional | Bioteque America, Inc. | 06/17/2004SE |
| K032835 | H/S Catheter SetLKF · Traditional | Catheter Research, Inc. | 12/11/2003SE |
| K023051 | Intrauterine Delivery System - InjectorLKF · Traditional | Prosurg, Inc. | 12/12/2002SE |
| K022503 | Uterine InjectorLKF · Traditional | Thomas Medical, Inc. | 10/25/2002SE |
| K021272 | Sib Catheter, Model 61-7005LKF · Special | Ackrad Laboratories | 05/21/2002SE |
| K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &…LKF · Special | Ackrad Laboratories | 04/24/2002SE |
| K020292 | Uterine InjectorLKF · Traditional | Catheter Research, Inc. | 04/17/2002SE |
| K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007LKF · Special | Ackrad Laboratories | 04/16/2002SE |
| K013972 | H/S Elliptosphere Catheter Set, Model 61-4005LKF · Special | Ackard Laboratories | 12/17/2001SE |
| K013491 | HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948LKF · Traditional | A & A Medical, Inc. | 11/19/2001SE |
| K013437 | SF SH Catheter, Model R65-945LKF · Traditional | A & A Medical, Inc. | 11/19/2001SE |
| K010296 | Uterine Manipulator Injector Cannula, Model R57-450LKF · Traditional | Marina Medical Instruments, Inc. | 04/11/2001SE |
| K010056 | Uterine Manipulator Injector Cannula, Sterile, Model R 57-450LKF · Traditional | A & A Medical, Inc. | 02/01/2001SE |
| K000433 | PBN Hystero-Salpingography Catheter SetLKF · Traditional | Medical Device Technologies, Inc. | 06/16/2000SE |
| K001115 | Ultra Catheter SetLKF · Traditional | Lyco Enterprises, Inc. | 05/17/2000SE |
| K974357 | Uterine Manipulator/InjectorLKF · Traditional | Catheter Research, Inc. | 02/02/1998SE |
| K970492 | Intrauterine Insemination and Sonohysterography CatheterLKF · Traditional | Ackrad Laboratories | 04/09/1997SE |
| K961752 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | Ackrad Laboratories | 08/08/1996SE |
| K955446 | Conmed Vcare Retractor/ElevatorLKF · Traditional | Conmedcorp | 06/18/1996SE |
| K955508 | Rosch -Thurmond Fallopian Tube Catheterization SetLKF · Traditional | Cook Urological, Inc. | 02/26/1996SE |
| K946220 | Conmed Vcare (Vaginal-Cervical Ahluqalia's Retractor-Elevator) Retractor/ElevatorLKF · Traditional | Conmedcorp | 09/15/1995SE |
| K953034 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | Ackrad Laboratories | 08/29/1995SE |
| K943494 | HSG Catheter Set for HystersalpingographyLKF · Traditional | Lyco Enterprises, Inc. | 07/06/1995SE |
| K931167 | Ovamed Fallopian Ostial Access CatheterLKF · Traditional | Ovamed Corp. | 06/22/1995SE |
| K943448 | LuminLKF · Traditional | Utah Medical Products, Inc. | 04/11/1995SE |
| K931122 | Ovamed HSG CatheterLKF · Traditional | Ovamed Corp. | 01/30/1995SE |
| K932394 | Bernstein(Tm) Uterine ManipulatorLKF · Traditional | Gm Engineering, Inc. | 01/26/1995SE |
| K941458 | Uterine Manipulator/Injector with SpringLKF · Traditional | Zinnanti Surgical Instruments, Inc. | 01/25/1995SE |
| K941457 | Uterine Injector with SpringLKF · Traditional | Zinnanti Surgical Instruments, Inc. | 01/24/1995SE |
| K935023 | Godat Uterine Manipulator InjectorLKF · Traditional | Ideas For Medicine, Inc. | 01/04/1995SE |
| K933981 | Cervical CatheterLKF · Traditional | Conceptus, Inc. | 12/27/1994SE |
| K933723 | Conceptus Uterine CatheterLKF · Traditional | Conceptus, Inc. | 12/27/1994SE |
| K940681 | Clearview Uterine ManipulatorLKF · Traditional | Clinical Innovations, Inc. | 07/26/1994SE |
| K930867 | Auto Suture Disposable Uterine ManipulatorLKF · Traditional | United States Surgical, A Division of Tyco Healthc | 07/25/1994SE |
| K932115 | Rowden Uterine Manipulator Injector and RumiLKF · Traditional | Blairden Precision Instruments, Inc. | 06/24/1994SE |
| K931814 | Dmi Uterine Mobilizer/Elevator/CannulaLKF · Traditional | Diversified Medical Instruments, Inc. | 05/31/1994SE |
| K935434 | Obstetric-Gynecologic Specialized Manual InstrumentLKF · Traditional | United States Surgical, A Division of Tyco Healthc | 05/27/1994SE |
| K932432 | Kronner Reinforcing StyletteLKF · Traditional | Unimar, Inc. | 04/12/1994SE |
| K930038 | Cannula: Kahn, Jarco, Corson and RatchetLKF · Traditional | Thomasville Medical Assoc. | 02/18/1994SE |
| K911887 | Majoli Uterine Manipulator/InjectorLKF · Traditional | Cook Ob/Gyn | 07/26/1991SE |
| K904079 | Bard Uterine ManipulatorLKF · Traditional | C.R. Bard, Inc. | 02/07/1991SE |
| K902975 | Twin Balloon InjectorLKF · Traditional | Zinnanti Surgical Instruments, Inc. | 09/26/1990SE |
| K772230 | Cannula, Perfusion, Fallopian TubeLKF · Traditional | J. Sklar Mfg. Co., Inc. | 01/03/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1613-2022 Class II | Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0504-2024 Class II | CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For…Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component… | CooperSurgical, Inc. | 03/31/2022Open, Classified |
| Z-0503-2024 Class II | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during…Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component… | CooperSurgical, Inc. | 03/31/2022Open, Classified |
| Z-0502-2024 Class II | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during…Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component… | CooperSurgical, Inc. | 03/31/2022Open, Classified |
| Z-2118-2020 Class II | Clearview Total Uterine Manipulator (model UM750), The device is labeled in part…An incorrect component used during manufacturing. The uterine manipulator tip support does not have the… | Clinical Innovations, LLC | 05/30/2019Terminated |
| Z-1727-2015 Class II | Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and…Design of device may expose user to injury to fingers or body parts | CooperSurgical, Inc. | 05/18/2015Terminated |
| Z-2570-2014 Class II | CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/…Unsealed pouches. | CooperSurgical, Inc. | 07/03/2014Terminated |
| Z-1782-2014 Class II | Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model…Sterility of the device may be compromised due to unsealed pouch | CooperSurgical, Inc. | 05/13/2014Terminated |
| Z-0440-2013 Class II | Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The…Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances… | Cooper Surgical, Inc. | 10/31/2012Terminated |
| Z-0439-2013 Class II | Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended…Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances… | Cooper Surgical, Inc. | 10/31/2012Terminated |
| Z-1818-2008 | ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm…Inadequate package seal could compromise sterility. | Clinical Innovations, LLC | 05/12/2008Terminated |
| Z-1817-2008 | ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator…Inadequate package seal could compromise sterility. | Clinical Innovations, LLC | 05/12/2008Terminated |