HIG
- Product code
- HIG
- Device name
- Insufflator, Hysteroscopic
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 57 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261706 | 2026-07-16 | KARL STORZ SE & CO. KG | Endomat Select (UP220) | |
| K251273 | 2026-03-27 | Boston Scientific Corporation | Asurys Fluid Management System | |
| K240886 | 2024-07-25 | Hologic, Inc. | Fluent Pro Fluid Management System (FLT-200); Fluent… |
Official FDA classification page: HIG
Classification and pathway per current FDA publications. Data from openFDA (CC0).