Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
The Hysteroscopic Fluid Insufflator with Closed-Loop Recirculation and Bipolar Endoscopic Cutter-Coagulator is a combined device for distending the uterus with saline and maintaining distension through closed-loop recirculation of filtered fluid during diagnostic and operative hysteroscopy, while also enabling cutting and coagulation of uterine tissue. It is an FDA Class 2 device regulated under 21 CFR 884.1710, requiring 510(k) premarket notification, within the Obstetrics and Gynecology (OB) specialty. The product code is PGT. This device is not implantable and does not sustain life.
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Basic Information
- Product Code
- PGT
- Device Class
- FDA class 2
- Regulation Number
- 884.1710
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.