Twin Balloon Injector
FDA 510(k) K902975 · Zinnanti Surgical Instruments, Inc.
510(k) numberK902975
Submission
- Device name
- Twin Balloon Injector
- Applicant
- Zinnanti Surgical Instruments, Inc.
Chatsworth, CA, US - Received
- July 6, 1990
- Decision date
- September 26, 1990
- 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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| 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 |
|---|---|---|
| K925501 | Nylon Coated SpeculaHIB · Traditional | 06/13/1997SE |
| K941458 | Uterine Manipulator/Injector with SpringLKF · Traditional | 01/25/1995SE |
| K941457 | Uterine Injector with SpringLKF · Traditional | 01/24/1995SE |
| K925560 | Zsi Loop, Zsi Ball & Zsi Needle ElectrodesHGI · Traditional | 08/30/1994SE |
| K925960 | Forceps for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K925957 | Scissors for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K926021 | Needle Holders & Access for Lapar Surg-Ob/Gyn UseHET · Traditional | 04/07/1994SE |
| K925958 | Scissor for Laparoscopic Surgery Gu UseGCJ · Traditional | 03/24/1994SE |
| K926181 | Zsi Laparoscopes-General & Plastic SurgeryGCJ · Traditional | 12/17/1993SE |
| K926016 | Needle Holders & Access for Lapar Surg-Gu UseGCJ · Traditional | 11/12/1993SE |
Questions and answers
When was Twin Balloon Injector cleared by the FDA?
Twin Balloon Injector (K902975) received a 510(k) decision of Substantially Equivalent on September 26, 1990, 82 days after the submission was received.
What is the product code of K902975?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.