FDA Product Code
FDA Product Code HES — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1300
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140761 | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA | Carefusion 2200, Inc. | 2014-04-21 | Special | PDF ↗ |
| K000340 | HYSTALOG HSG CATHETER | Rocket Medical Plc | 2000-04-19 | Traditional | PDF ↗ |
| K903209 | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER | Adler Instrument Co. | 1990-12-21 | Traditional | PDF ↗ |
| K903208 | MAXI-FLOW INSUFFLATOR TUBING SET | Adler Instrument Co. | 1990-12-17 | Traditional | PDF ↗ |
| K904473 | KRONNER MANIPUJECTOR | Unimar, Inc. | 1990-12-14 | Traditional | PDF ↗ |
| K901413 | CORE DISPOSABLE INSUFFLATION TUBING | Core Dynamics, Inc. | 1990-09-24 | Traditional | PDF ↗ |
| K891290 | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER | Cook Ob/Gyn | 1989-05-23 | Traditional | PDF ↗ |
| K890869 | BARD HYSTEROSALPINGOGRAPHY CATHETERS | C.R. Bard, Inc. | 1989-04-25 | Traditional | PDF ↗ |
| K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | F.M. Wiest USA, Inc. | 1988-03-02 | Traditional | PDF ↗ |
| K873515 | UTERINE INJECTOR 2MM | Zinnanti Surgical Instruments, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K862310 | CABOT MEDICAL VARIABLE FLOW INSUFFLATOR | Cabot Medical Corp. | 1986-08-12 | Traditional | PDF ↗ |
| K844173 | FEMTEST | Bionexus, Inc. | 1985-08-14 | Traditional | PDF ↗ |
| K841682 | UTERINE INJECTOR 4.0MM | Humi Corp. | 1984-07-03 | Traditional | PDF ↗ |
Product code HES · Class II · Obstetrics/Gynecology. Data: openFDA.