Cervical Catheter
FDA 510(k) K933981 · Conceptus, Inc.
510(k) numberK933981
Submission
- Device name
- Cervical Catheter
- Applicant
- Conceptus, Inc.
San Carlos, CA, US - Received
- August 16, 1993
- Decision date
- December 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| 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 |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K974028 | Stargate Falloposcopy Catheter, Trifurcated Irrigation TubingMKO · Traditional | 01/21/1998SE |
| K972210 | Resectoscope Safety SheathHIH · Traditional | 09/05/1997SE |
| K962587 | Conceptus Fallopian Tube Catheteization with Microendoscopy SystemMKO · Traditional | 01/31/1997SE |
| K954164 | HysteroscopeHIH · Traditional | 03/12/1996SE |
| K953314 | Conceptus Fallopian Tube Catheterization SystemMOV · Traditional | 07/28/1995SE |
| K932387 | Conceptus Vari-Soft Cath/Pirouette Posit MandrelHET · Traditional | 03/06/1995SE |
| K932993 | Intrauterine Catheter and IntroducerMFD · Traditional | 01/06/1995SE |
| K933723 | Conceptus Uterine CatheterLKF · Traditional | 12/27/1994SE |
Questions and answers
When was Cervical Catheter cleared by the FDA?
Cervical Catheter (K933981) received a 510(k) decision of Substantially Equivalent on December 27, 1994, 498 days after the submission was received.
What is the product code of K933981?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.