Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
The Carbon-Dioxide Uterotubal Insufflator (and accessories) is a device used to introduce carbon dioxide gas into the uterine cavity and fallopian tubes, typically to assess tubal patency as part of an infertility evaluation. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HES, regulated under 21 CFR 884.1300, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
Basic Information
- Product Code
- HES
- Device Class
- FDA class 2
- Regulation Number
- 884.1300
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140761 | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA | Apr 21, 2014 | Substantially Equivalent | CAREFUSION 2200 INC. |
| K000340 | HYSTALOG HSG CATHETER | Apr 19, 2000 | Substantially Equivalent | ROCKET MEDICAL PLC |
| K903209 | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER | Dec 21, 1990 | Substantially Equivalent | ADLER INSTRUMENT CO. |
| K903208 | MAXI-FLOW INSUFFLATOR TUBING SET | Dec 17, 1990 | Substantially Equivalent | ADLER INSTRUMENT CO. |
| K904473 | KRONNER MANIPUJECTOR | Dec 14, 1990 | Substantially Equivalent | UNIMAR, INC. |
| K901413 | CORE DISPOSABLE INSUFFLATION TUBING | Sep 24, 1990 | Substantially Equivalent | CORE DYNAMICS, INC. |
| K891290 | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER | May 23, 1989 | Substantially Equivalent | COOK OB/GYN |
| K890869 | BARD HYSTEROSALPINGOGRAPHY CATHETERS | Apr 25, 1989 | Substantially Equivalent | C.R. BARD, INC. |
| K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | Mar 02, 1988 | Substantially Equivalent | F.M. WIEST USA, INC. |
| K873515 | UTERINE INJECTOR 2MM | Sep 29, 1987 | Substantially Equivalent | ZINNANTI SURGICAL INSTRUMENTS, INC. |
| K862310 | CABOT MEDICAL VARIABLE FLOW INSUFFLATOR | Aug 12, 1986 | Substantially Equivalent | CABOT MEDICAL CORP. |
| K844173 | FEMTEST | Aug 14, 1985 | Substantially Equivalent | BIONEXUS, INC. |
| K841682 | UTERINE INJECTOR 4.0MM | Jul 03, 1984 | Substantially Equivalent | HUMI CORP. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.