FDA product code HES: Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
HES is the FDA product code for insufflator, carbon-dioxide, uterotubal (and accessories). It is a Class II device, regulated under 21 CFR 884.1300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 13 510(k) submissions under HES, from 12 different applicants. The average 510(k) review took 102 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.1300 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HES clearance
Top HES applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adler Instrument Co. | 2 | 1990-12-21 |
| Carefusion 2200, Inc. | 1 | 2014-04-21 |
| Rocket Medical Plc | 1 | 2000-04-19 |
| Unimar, Inc. | 1 | 1990-12-14 |
| Core Dynamics, Inc. | 1 | 1990-09-24 |
7 more applicants have HES clearances. See the full list in Caduvo.
Most recent HES clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140761 | Carefusion 2200, Inc. | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA | 2014-04-21 | 26 |
| K000340 | Rocket Medical Plc | HYSTALOG HSG CATHETER | 2000-04-19 | 76 |
| K903209 | Adler Instrument Co. | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER | 1990-12-21 | 154 |
| K903208 | Adler Instrument Co. | MAXI-FLOW INSUFFLATOR TUBING SET | 1990-12-17 | 150 |
| K904473 | Unimar, Inc. | KRONNER MANIPUJECTOR | 1990-12-14 | 74 |
Recalls for HES devices
openFDA lists no recalls for product code HES.
Frequently asked questions
What is FDA product code HES?
HES is the FDA product code for insufflator, carbon-dioxide, uterotubal (and accessories). It is a Class II device, regulated under 21 CFR 884.1300 and reviewed by the Obstetrics and Gynecology panel.
What device class is HES?
Class II, regulation 21 CFR 884.1300. Typical premarket route: 510(k).
How long does a 510(k) take for product code HES?
Across 13 cleared submissions the average was 102 days from receipt to decision (median 74).
Which companies have the most HES clearances?
Adler Instrument Co. (2); Carefusion 2200, Inc. (1); Rocket Medical Plc (1); Unimar, Inc. (1); Core Dynamics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HES
- Run a recall and safety report across every HES manufacturer
- Watch product code HES for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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