Kronner Manipujector
FDA 510(k) K904473 · Unimar, Inc.
510(k) numberK904473
Submission
- Device name
- Kronner Manipujector
- Applicant
- Unimar, Inc.
Wilton, CT, US - Received
- October 1, 1990
- Decision date
- December 14, 1990
- 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 |
| 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 |
| K873515 | Uterine Injector 2MMHES · Traditional | Zinnanti Surgical Instruments, Inc. | 09/29/1987SE |
| K862310 | Cabot Medical Variable Flow InsufflatorHES · Traditional | Cabot Medical Corp. | 08/12/1986SE |
More from Cabot Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K932432 | Kronner Reinforcing StyletteLKF · Traditional | 04/12/1994SE |
| K920803 | HSG TrayHIB · Traditional | 10/19/1992SEKD |
| K910317 | Uni-Sem(Tm)MFD · Traditional | 05/01/1991SE |
| K895659 | Hui Mini-FlexHIG · Traditional | 12/19/1989SE |
| K895403 | Aspirette Endocervical AspiratorHFC · Traditional | 11/29/1989SE |
| K894264 | KDF-2.3HDR · Traditional | 08/15/1989SE |
| K890848 | Cervex-BrushHHT · Traditional | 05/11/1989SE |
| K854415 | Endometrial PipelleHHK · Traditional | 03/13/1986SE |
| K810291 | Sterile/Disposable HSG TrayEYY · Traditional | 03/18/1981SE |
Questions and answers
When was Kronner Manipujector cleared by the FDA?
Kronner Manipujector (K904473) received a 510(k) decision of Substantially Equivalent on December 14, 1990, 74 days after the submission was received.
What is the product code of K904473?
The FDA product code is HES – Insufflator, Carbon-Dioxide, Uterotubal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1300.