Search Results
Found 1 results
510(k) Data Aggregation
K Number
K182675Device Name
Polygon Resection Device
Manufacturer
Date Cleared
2019-01-04
(100 days)
Product Code
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
Polygon Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Polygon Resection Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.
Device Description
The Polygon Resection Device is a handheld manually operated device designed for the hysteroscopic removal of intrauterine tissue. The device is provided sterile. The shaft of the device is design to fit into the working channel of any hysteroscope that includes a 3.0 mm (Fr) straight working channel. The device is activated by the physician by squeezing the trigger. A rotation knob is provided to enable the physician to rotate the cutting bay into an orientation that aligns with the desired specimen. The barb fitting provides an attachment port for a vacuum system. The vacuum system pulls the specimen into the cutting window where it can be resected and aspirated out of the patient. There are no electrical or powered connections necessary for operation of the device.
Ask a Question
Ask a specific question about this device
Page 1 of 1