Panels › Obstetrics/Gynecology › Product code HES · Class 2
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Regulation 884.1300
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HES
| Company | 510(k)s | Recalls |
|---|---|---|
| Adler Instrument Co. | 2 | 0 |
| Bionexus, Inc. | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Cabot Medical Corp. | 1 | 0 |
| Carefusion 2200, Inc. | 1 | 0 |
| Cook Ob/Gyn | 1 | 0 |
| Core Dynamics, Inc. | 1 | 0 |
| F.M. Wiest USA, Inc. | 1 | 0 |
| Humi Corp. | 1 | 0 |
| Rocket Medical Plc | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 2014 | K140761 | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA Carefusion 2200, Inc. | HES |
| Apr 19, 2000 | K000340 | HYSTALOG HSG CATHETER Rocket Medical Plc, GB | HES |
| Dec 21, 1990 | K903209 | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER Adler Instrument Co. | HES |
| Dec 17, 1990 | K903208 | MAXI-FLOW INSUFFLATOR TUBING SET Adler Instrument Co. | HES |
| Dec 14, 1990 | K904473 | KRONNER MANIPUJECTOR Unimar, Inc. | HES |
| Sep 24, 1990 | K901413 | CORE DISPOSABLE INSUFFLATION TUBING Core Dynamics, Inc. | HES |
| May 23, 1989 | K891290 | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER Cook Ob/Gyn | HES |
| Apr 25, 1989 | K890869 | BARD HYSTEROSALPINGOGRAPHY CATHETERS C.R. Bard, Inc. | HES |
| Mar 2, 1988 | K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC F.M. Wiest USA, Inc. | HES |
| Sep 29, 1987 | K873515 | UTERINE INJECTOR 2MM Zinnanti Surgical Instruments, Inc. | HES |
| Aug 12, 1986 | K862310 | CABOT MEDICAL VARIABLE FLOW INSUFFLATOR Cabot Medical Corp. | HES |
| Aug 14, 1985 | K844173 | FEMTEST Bionexus, Inc. | HES |
| Jul 3, 1984 | K841682 | UTERINE INJECTOR 4.0MM Humi Corp. | HES |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.