HES
13 FDA 510(k) clearances · Product code
74 daysmedian time to decision
182 days90th percentile
13clearances measured
FDA profile
- Official device name
- Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1300
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1 · 1996: 1 · 2017: 29 · 2018: 68 · 2019: 31 · 2020: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (K140761) | Carefusion 2200, Inc. | 2014-04-21 |
| HYSTALOG HSG CATHETER (K000340) | Rocket Medical Plc | 2000-04-19 |
| MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER (K903209) | Adler Instrument Co. | 1990-12-21 |
| MAXI-FLOW INSUFFLATOR TUBING SET (K903208) | Adler Instrument Co. | 1990-12-17 |
| KRONNER MANIPUJECTOR (K904473) | Unimar, Inc. | 1990-12-14 |
| CORE DISPOSABLE INSUFFLATION TUBING (K901413) | Core Dynamics, Inc. | 1990-09-24 |
| SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER (K891290) | Cook Ob/Gyn | 1989-05-23 |
| BARD HYSTEROSALPINGOGRAPHY CATHETERS (K890869) | C.R. Bard, Inc. | 1989-04-25 |
| LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (K875137) | F.M. Wiest USA, Inc. | 1988-03-02 |
| UTERINE INJECTOR 2MM (K873515) | Zinnanti Surgical Instruments, Inc. | 1987-09-29 |
| CABOT MEDICAL VARIABLE FLOW INSUFFLATOR (K862310) | Cabot Medical Corp. | 1986-08-12 |
| FEMTEST (K844173) | Bionexus, Inc. | 1985-08-14 |
| UTERINE INJECTOR 4.0MM (K841682) | Humi Corp. | 1984-07-03 |
Track HES automatically
Every clearance here is in the API, with alerts when new ones post.