Data / Medical devices / Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar (PGT): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar (product code PGT, Class 2, 21 CFR 884.1710). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on January 17, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PGT
- Device class
- 2
- Regulation
- 884.1710
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Costa Rica | 1 |
Makers of Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Axora Medical, Inc. | Sunnyvale, CA, United States | Complaint file establishment, Specification developer | 2 | January 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Minerva Surgical, Inc. | Santa Clara, CA, United States | Manufacturer, Remanufacturer | 2 | January 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMC Costa Rica Division S.R.L. | El Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.