Cannula, Perfusion, Fallopian Tube
FDA 510(k) K772230 · J. Sklar Mfg. Co., Inc.
510(k) numberK772230
Submission
- Device name
- Cannula, Perfusion, Fallopian Tube
- Applicant
- J. Sklar Mfg. Co., Inc.
Walker, MI, US - Received
- December 6, 1977
- Decision date
- January 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
|---|---|---|
| K843693 | Jacobs High Vacuum Suction Unit 05-2570BTA · Traditional | 10/31/1984SE |
| K842112 | Tischler Cervical Biopsy Punch ForcepsHFB · Traditional | 07/03/1984SE |
| K842111 | Kogan Endospeculum 9-1/2HTZ · Traditional | 06/19/1984SE |
| K822448 | Scissors, VariousFZT · Traditional | 09/14/1982SE |
| K802458 | Kevorkian-Younge Biopsy Curette #90-6611HFB · Traditional | 01/12/1981SE |
| K802457 | Kevorkian-Younge Biopsy Punch, #90-6610HFB · Traditional | 01/12/1981SE |
| K801273 | Magill Catheter Intro. ForcepsKOA · Traditional | 07/28/1980SE |
| K800441 | Rudd-Clinic Hemorrhoidal ForcepsKOA · Traditional | 04/08/1980SE |
| K790577 | Hemorrhoidal LigatorHCF · Traditional | 04/23/1979SE |
| K772229 | Miniclamps, Stabiliz., Fallopian TubeHCZ · Traditional | 01/03/1978SE |
Questions and answers
When was Cannula, Perfusion, Fallopian Tube cleared by the FDA?
Cannula, Perfusion, Fallopian Tube (K772230) received a 510(k) decision of Substantially Equivalent on January 3, 1978, 28 days after the submission was received.
What is the product code of K772230?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.