H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)
FDA 510(k) K953034 · Ackrad Laboratories
510(k) numberK953034
Submission
- Device name
- H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)
- Applicant
- Ackrad Laboratories
Cranford, NJ, US - Received
- June 19, 1995
- Decision date
- August 29, 1995
- 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
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 |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K021272 | Sib Catheter, Model 61-7005LKF · Special | 05/21/2002SE |
| K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &…LKF · Special | 04/24/2002SE |
| K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007LKF · Special | 04/16/2002SE |
| K970492 | Intrauterine Insemination and Sonohysterography CatheterLKF · Traditional | 04/09/1997SE |
| K961752 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | 08/08/1996SE |
| K952542 | Ackrad Esophageal Balloon Catheter SetBZC · Traditional | 04/23/1996SE |
| K940176 | Ackrad Iui Set for Intrauterine InseminationMFD · Traditional | 04/23/1996SE |
| K915813 | Ackrad Ercp Contrast Delivery SetFGE · Traditional | 03/11/1992SE |
| K904499 | Nicos (Non-Invasive Cardiac Output System)KFG · Traditional | 07/01/1991SE |
| K911780 | Infant Nasal Cannulae Assembly, ModifiedBZD · Traditional | 06/24/1991SE |
Questions and answers
When was H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607) cleared by the FDA?
H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607) (K953034) received a 510(k) decision of Substantially Equivalent on August 29, 1995, 71 days after the submission was received.
What is the product code of K953034?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.