FDA product code HIG: Insufflator, Hysteroscopic
HIG is the FDA product code for insufflator, hysteroscopic. It is a Class II device, regulated under 21 CFR 884.1700 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 57 510(k) submissions under HIG, 3 in the last five years, from 34 different applicants. The average 510(k) review took 245 days (median 178); 156 days on average over the last three years. FDA has posted 6 recalls for HIG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Insufflator, Hysteroscopic |
| Device class | Class II |
| Regulation | 21 CFR 884.1700 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HIG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 61 |
| 2018 | 4 | 175 |
| 2020 | 1 | 62 |
| 2021 | 1 | 247 |
| 2024 | 1 | 115 |
| 2026 | 2 | 196 |
Compare with all 510(k) review times · Search every HIG clearance
Top HIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W.O.M. World of Medicine GmbH | 6 | 2018-03-28 |
| Davol Inc., Sub. C. R. Bard, Inc. | 5 | 2001-08-16 |
| Thermedx, LLC | 4 | 2021-11-04 |
| W.O.M. World of Medicine AG | 4 | 2013-04-04 |
| KARL STORZ Endoscopy-America, Inc. | 4 | 2000-11-30 |
29 more applicants have HIG clearances. See the full list in Caduvo.
Most recent HIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261706 | KARL STORZ SE & CO. KG | Endomat Select (UP220) | 2026-07-16 | 55 |
| K251273 | Boston Scientific Corporation | Asurys Fluid Management System | 2026-03-27 | 337 |
| K240886 | Hologic, Inc. | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | 2024-07-25 | 115 |
| K210628 | Thermedx, LLC | X-FLO Fluid Management System | 2021-11-04 | 247 |
| K201355 | Karl Storz SE & CO. KG | Endomat Select, IBS Shaver Software, License | 2020-07-22 | 62 |
Recalls for HIG devices
6 product recalls in 6 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2026-04-09.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HIG?
HIG is the FDA product code for insufflator, hysteroscopic. It is a Class II device, regulated under 21 CFR 884.1700 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIG?
Class II, regulation 21 CFR 884.1700. Typical premarket route: 510(k).
How long does a 510(k) take for product code HIG?
Across 57 cleared submissions the average was 245 days from receipt to decision (median 178).
Which companies have the most HIG clearances?
W.O.M. World of Medicine GmbH (6); Davol Inc., Sub. C. R. Bard, Inc. (5); Thermedx, LLC (4); W.O.M. World of Medicine AG (4); KARL STORZ Endoscopy-America, Inc. (4).
Have HIG devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2026-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code HIG
- Run a recall and safety report across every HIG manufacturer
- Watch product code HIG 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.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times