510(k) K140761
- Device
- KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
- Applicant
- CAREFUSION 2200 INC.
- 510(k) number
- K140761
- Product code
- HES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-21
- Date received
- 2014-03-26
- Regulation
- 884.1300
- Classification name
- Insufflator, Carbon-dioxide, Uterotubal (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANE WEBER
- Address
- 72 N. Fairway Dr. Vernon Hills IL US 60061 60061
FDA Registration Numbers#
- 9610632
- 3002807315
- 1321175
- 3004491689
- 1216677
- 1923569
- 2246552
- 1820334
- 3007305485
- 1320894
- 1825146
Source Documents#
Other 510(k) Records For Product Code HES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000340 | HYSTALOG HSG CATHETER | Rocket Medical Plc | 2000-04-19 |
| K903209 | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER | Adler Instrument Co. | 1990-12-21 |
| K903208 | MAXI-FLOW INSUFFLATOR TUBING SET | Adler Instrument Co. | 1990-12-17 |
| K904473 | KRONNER MANIPUJECTOR | Unimar, Inc. | 1990-12-14 |
| K901413 | CORE DISPOSABLE INSUFFLATION TUBING | Core Dynamics, Inc. | 1990-09-24 |
| K891290 | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER | Cook Ob/Gyn | 1989-05-23 |
| K890869 | BARD HYSTEROSALPINGOGRAPHY CATHETERS | C.R. Bard, Inc. | 1989-04-25 |
| K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | F.M. Wiest USA, Inc. | 1988-03-02 |
| K873515 | UTERINE INJECTOR 2MM | Zinnanti Surgical Instruments, Inc. | 1987-09-29 |
| K862310 | CABOT MEDICAL VARIABLE FLOW INSUFFLATOR | Cabot Medical Corp. | 1986-08-12 |
| K844173 | FEMTEST | Bionexus, Inc. | 1985-08-14 |
| K841682 | UTERINE INJECTOR 4.0MM | Humi Corp. | 1984-07-03 |
Legacy Summary#
summary
FDA Review#
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