510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PGTClass II

Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

21 CFR 884.1710 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PGT is the FDA product code for Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar, a class II device type, regulated under 21 CFR 884.1710. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PGT
Device name
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
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.
Regulation
21 CFR 884.1710
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PGT

By decision year
3 clearances under product code PGT with a decision year between 2014 and 2024, 2014 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PGT by decision year
YearClearances
20142
20241

Applicants with the most clearances

Product code PGT
Applicants holding the most 510(k) clearances under product code PGT
ApplicantClearances
Iogyn, Inc.2
Minerva Surgical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code