H/S Catheter Set
FDA 510(k) K032835 · Catheter Research, Inc.
510(k) numberK032835
Submission
- Device name
- H/S Catheter Set
- Applicant
- Catheter Research, Inc.
Indianapolis, IN, US - Received
- September 11, 2003
- Decision date
- December 11, 2003
- 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 |
|---|---|---|
| K123258 | The Advance Catheter for HSG and SisLKF · Special | 01/31/2013SE |
| K120154 | Intrauterine Insemination (Iui) CatheterMQF · Abbreviated | 03/21/2012SE |
| K020292 | Uterine InjectorLKF · Traditional | 04/17/2002SE |
| K973839 | Disposable Esophageal StethoscopeBZT · Traditional | 03/19/1998SE |
| K974357 | Uterine Manipulator/InjectorLKF · Traditional | 02/02/1998SE |
| K951345 | Disposable Airway Connectors for Gas SamplingBZA · Traditional | 04/14/1995SE |
| K946044 | Disposable Gas Sampling LinesCCK · Traditional | 12/27/1994SE |
Questions and answers
When was H/S Catheter Set cleared by the FDA?
H/S Catheter Set (K032835) received a 510(k) decision of Substantially Equivalent on December 11, 2003, 91 days after the submission was received.
What is the product code of K032835?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.