HES · Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.1300 · Class 2
Overview
| Product Code | HES |
|---|---|
| Device Name | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) |
| Regulation | 21 CFR 884.1300 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140761 | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA | Carefusion 2200, Inc. | Apr 21, 2014 | SESE |
| K000340 | HYSTALOG HSG CATHETER | Rocket Medical Plc | Apr 19, 2000 | SESE |
| K903209 | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER | Adler Instrument Co. | Dec 21, 1990 | SESE |
| K903208 | MAXI-FLOW INSUFFLATOR TUBING SET | Adler Instrument Co. | Dec 17, 1990 | SESE |
| K904473 | KRONNER MANIPUJECTOR | Unimar, Inc. | Dec 14, 1990 | SESE |
| K901413 | CORE DISPOSABLE INSUFFLATION TUBING | Core Dynamics, Inc. | Sep 24, 1990 | SESE |
| K891290 | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER | Cook Ob/Gyn | May 23, 1989 | SESE |
| K890869 | BARD HYSTEROSALPINGOGRAPHY CATHETERS | C.R. Bard, Inc. | Apr 25, 1989 | SESE |
| K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | F.M. Wiest USA, Inc. | Mar 2, 1988 | SESE |
| K873515 | UTERINE INJECTOR 2MM | Zinnanti Surgical Instruments, Inc. | Sep 29, 1987 | SESE |
| K862310 | CABOT MEDICAL VARIABLE FLOW INSUFFLATOR | Cabot Medical Corp. | Aug 12, 1986 | SESE |
| K844173 | FEMTEST | Bionexus, Inc. | Aug 14, 1985 | SESE |
| K841682 | UTERINE INJECTOR 4.0MM | Humi Corp. | Jul 3, 1984 | SESE |
Top Applicants
- Adler Instrument Co. — 2 clearances
- Bionexus, Inc. — 1 clearance
- C.R. Bard, Inc. — 1 clearance
- Cabot Medical Corp. — 1 clearance
- Carefusion 2200, Inc. — 1 clearance
