Uterine Injector 2MM
FDA 510(k) K873515 · Zinnanti Surgical Instruments, Inc.
510(k) numberK873515
Submission
- Device name
- Uterine Injector 2MM
- Applicant
- Zinnanti Surgical Instruments, Inc.
Woodland Hills, CA, US - Received
- August 31, 1987
- Decision date
- September 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HES – Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1300
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HES
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140761 | Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian CannulaHES · Special | Carefusion 2200, Inc. | 04/21/2014SE |
| K000340 | Hystalog HSG CatheterHES · Traditional | Rocket Medical Plc | 04/19/2000SE |
| K903209 | Maxi-Flow Insufflator Tubing Set W/FilterHES · Traditional | Adler Instrument Co. | 12/21/1990SE |
| K903208 | Maxi-Flow Insufflator Tubing SetHES · Traditional | Adler Instrument Co. | 12/17/1990SE |
| K904473 | Kronner ManipujectorHES · Traditional | Unimar, Inc. | 12/14/1990SE |
| K901413 | Core Disposable Insufflation TubingHES · Traditional | Core Dynamics, Inc. | 09/24/1990SE |
| K891290 | Sholkoff Balloon Hysterosalpingography CatheterHES · Traditional | Cook Ob/Gyn | 05/23/1989SE |
| K890869 | Bard Hysterosalpingography CathetersHES · Traditional | C.R. Bard, Inc. | 04/25/1989SE |
| K875137 | Laparoflator 3000, Standard and ElectronicHES · Traditional | F.M. Wiest USA, Inc. | 03/02/1988SE |
| K862310 | Cabot Medical Variable Flow InsufflatorHES · Traditional | Cabot Medical Corp. | 08/12/1986SE |
More from Cabot Medical Corp.
| 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 Injector 2MM cleared by the FDA?
Uterine Injector 2MM (K873515) received a 510(k) decision of Substantially Equivalent on September 29, 1987, 29 days after the submission was received.
What is the product code of K873515?
The FDA product code is HES – Insufflator, Carbon-Dioxide, Uterotubal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1300.