PGT
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1710
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy. It is also intended for cutting and coagulation of uterine tissue.
- Adverse events (MAUDE)
- 2016: 19 · 2017: 39 · 2018: 17 · 2019: 13
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 |
|---|---|---|
| Symphion Operative Hysteroscopy System (K233710) | Minerva Surgical, Inc. | 2024-01-17 |
| IOGYN SYSTEM (K141848) | Iogyn, Inc. | 2014-08-29 |
| IOGYN SYSTEM (DEN130040) | Iogyn, Inc. | 2014-03-28 |
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Every clearance here is in the API, with alerts when new ones post.