Majoli Uterine Manipulator/Injector
FDA 510(k) K911887 · Cook Ob/Gyn
510(k) numberK911887
Submission
- Device name
- Majoli Uterine Manipulator/Injector
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- April 29, 1991
- Decision date
- July 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code LKF
| 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 |
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|---|---|---|
| K062438 | Bakri Postpartum Balloon, Model J-SOS-100500KNA · Traditional | 10/27/2006SE |
| K030441 | Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw KitMQL · Traditional | 08/29/2003SE |
| K023850 | Sydney Ivf Embryo Biopsy MediumMQL · Traditional | 01/22/2003SE |
| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | 04/17/2002SE |
| K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…MQL · Traditional | 09/18/2000SE |
| K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient KitMQL · Traditional | 09/13/2000SE |
| K983595 | Transmyometrial Embryo Transfer SetMQF · Traditional | 02/08/1999SE |
| K983596 | Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes…MQH · Traditional | 02/05/1999SE |
| K983642 | Cook Mini-IncubatorMQG · Traditional | 02/01/1999SE |
| K983593 | Ovum Pick-Up Aspiration NeedlesMQE · Traditional | 01/21/1999SE |
Questions and answers
When was Majoli Uterine Manipulator/Injector cleared by the FDA?
Majoli Uterine Manipulator/Injector (K911887) received a 510(k) decision of Substantially Equivalent on July 26, 1991, 88 days after the submission was received.
What is the product code of K911887?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.