HIF
- Product code
- HIF
- Device name
- Insufflator, Laparoscopic
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 179
510(k) clearances, last 3 years (13)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260209 | 2026-08-19 | Karl Storz SE & CO. KG | ENDOFLATOR+; Smart Smoke Evacuation | |
| K252584 | 2026-06-25 | Weyo Surgical Technology , Ltd. | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, | |
| K252318 | 2026-04-16 | Guangdong Optomedic Technologies, Inc. | Insufflator (OPTO-IFL1000) | |
| K250388 | 2025-09-22 | Karl Storz SE & CO. KG | ENDOFLATOR + | |
| K242772 | 2025-04-11 | SmartsurgN, Inc. | AirSurgN Insufflator (10030/AirSurgN) | |
| K243527 | 2025-01-13 | Olympus Medical Systems Corporation | High Flow Insufflation Unit (UHI-4) | |
| K242536 | 2024-10-15 | Tautona Group | TauTona Pneumoperitoneum Assist Device (TPAD) | |
| K232464 | 2024-05-02 | Freyja Healthcare, LLC | VereSee Optical Veres Needle System | |
| K232902 | 2024-05-02 | Palliare , Ltd. | EVA15 insufflator | |
| K233020 | 2024-01-12 | Tautona Group Research & Development, | TauTona Pneumoperitoneum Assist Device (TPAD) | |
| K232401 | 2023-12-14 | Hangzhou Kangji Medical Instrument Co. | Disposable Veress Needles | |
| K230239 | 2023-09-20 | Conmed Corporation | AirSeal iFS System; AirSeal dV Solution | |
| K231342 | 2023-09-20 | Guangdong Optomedic Technologies, Inc. | Insufflator (OPTO-IFL1000) |
Official FDA classification page: HIF
Classification and pathway per current FDA publications. Data from openFDA (CC0).