Uterine Cannula - Kahn, Jarco, Corson, Ratchet
FDA 510(k) K891028 · Zinnanti Surgical Instruments, Inc.
510(k) numberK891028
Submission
- Device name
- Uterine Cannula - Kahn, Jarco, Corson, Ratchet
- Applicant
- Zinnanti Surgical Instruments, Inc.
Chatsworth, CA, US - Received
- February 28, 1989
- Decision date
- March 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIG – Insufflator, Hysteroscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1700
- Specialty
- Obstetrics/Gynecology
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| K173489 | GYN-Pump PH304HIG · Traditional | W.O.M. World of Medicine GmbH | 03/28/2018SE |
| K172040 | Aquilex Fluid Control System AQL-100SHIG · Special | W.O.M. World of Medicine GmbH | 02/05/2018SE |
| K172048 | FluidSmartHIG · Special | Thermedx, LLC | 09/05/2017SE |
More from Thermedx, LLC
| 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 Uterine Cannula - Kahn, Jarco, Corson, Ratchet cleared by the FDA?
Uterine Cannula - Kahn, Jarco, Corson, Ratchet (K891028) received a 510(k) decision of Substantially Equivalent on March 17, 1989, 17 days after the submission was received.
What is the product code of K891028?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.