HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948
FDA 510(k) K013491 · A & A Medical, Inc.
510(k) numberK013491
Submission
- Device name
- HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948
- Applicant
- A & A Medical, Inc.
Alpharetta, GA, US - Received
- October 22, 2001
- Decision date
- November 19, 2001
- 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 |
|---|---|---|
| K013437 | SF SH Catheter, Model R65-945LKF · Traditional | 11/19/2001SE |
| K003949 | Tacker, Model R65-933OCW · Traditional | 07/25/2001SE |
| K011512 | Mmodification to LaminariaHDY · Traditional | 07/09/2001SE |
| K010510 | Balloon Cannula, Short, Model R65-985; Balloon Cannula, Long, Model R65-985-1HET · Traditional | 05/16/2001SE |
| K010789 | Cannula, Surgical General & Plastic Surgery, MODELR65-995, R65-995-1, R65-995-2…GCJ · Traditional | 04/27/2001SE |
| K010056 | Uterine Manipulator Injector Cannula, Sterile, Model R 57-450LKF · Traditional | 02/01/2001SE |
| K000027 | Insufflation Needle, Model R65-933HIF · Traditional | 04/03/2000SE |
| K994256 | Suction Irrigation Trumpet Valve Set, Model Q65-823GCJ · Traditional | 02/03/2000SE |
| K974038 | The Aspirator, 6FT Silicone Tubing, Metal Tubing Adapter, Glass Reservoir, Neoprene…JCX · Traditional | 05/11/1998SE |
| K974138 | Rocket ElectrodeHGI · Traditional | 01/30/1998SE |
Questions and answers
When was HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948 cleared by the FDA?
HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948 (K013491) received a 510(k) decision of Substantially Equivalent on November 19, 2001, 28 days after the submission was received.
What is the product code of K013491?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.