FDA product code PGT: Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
PGT is the FDA product code for insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar. It is a Class II device, regulated under 21 CFR 884.1710 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under PGT, 1 in the last five years, from 2 different applicants. The average 510(k) review took 54 days (median 54); 58 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar |
| Device class | Class II |
| Regulation | 21 CFR 884.1710 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for PGT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 58 |
Compare with all 510(k) review times · Search every PGT clearance
Top PGT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Minerva Surgical, Inc. | 1 | 2024-01-17 |
| Iogyn, Inc. | 1 | 2014-08-29 |
Most recent PGT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233710 | Minerva Surgical, Inc. | Symphion Operative Hysteroscopy System | 2024-01-17 | 58 |
| K141848 | Iogyn, Inc. | IOGYN SYSTEM | 2014-08-29 | 51 |
Recalls for PGT devices
openFDA lists no recalls for product code PGT.
Frequently asked questions
What is FDA product code PGT?
PGT is the FDA product code for insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar. It is a Class II device, regulated under 21 CFR 884.1710 and reviewed by the Obstetrics and Gynecology panel.
What device class is PGT?
Class II, regulation 21 CFR 884.1710. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGT?
Across 2 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most PGT clearances?
Minerva Surgical, Inc. (1); Iogyn, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PGT
- Run a recall and safety report across every PGT manufacturer
- Watch product code PGT 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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