HIG — Insufflator, Hysteroscopic Class II
FDA Device Classification
Classification Details
- Product Code
- HIG
- Device Class
- Class II
- Regulation Number
- 884.1700
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K240886 | hologic | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System | July 25, 2024 |
| K210628 | thermedx | X-FLO Fluid Management System | November 4, 2021 |
| K201355 | karl storz se and co. kg | Endomat Select, IBS Shaver Software, License | July 22, 2020 |
| K180735 | karl storz se and co. kg | Endomat Select | October 31, 2018 |
| K180825 | hologic | Fluent Fluid Management System | August 3, 2018 |
| K173489 | w.o.m. world of medicine | GYN-Pump PH304 | March 28, 2018 |
| K172040 | w.o.m. world of medicine | Aquilex Fluid Control System AQL-100S | February 5, 2018 |
| K172048 | thermedx | FluidSmart | September 5, 2017 |
| K133799 | thermedx | THERMEDX FLUID MANAGMENT SYSTEM | June 20, 2014 |
| K123732 | w.o.m. world of medicine | HYSTEROSCOPY PUMP HM6 | April 4, 2013 |
| K112642 | w.o.m. world of medicine | AQUILEX FLUID CONTROL SYSTEM H112 | February 6, 2012 |
| K110852 | gyrus acmi | DOLPHIN 3 FLUID MANAGEMENT SYSTEM | July 19, 2011 |
| K091939 | thermedx | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | July 23, 2010 |
| K031616 | w.o.m. world of medicine | IUR FLUID MANAGEMENT SYSTEM | August 13, 2003 |
| K031213 | davol | AQUASENS FLUID MONITORING SYSTEM | April 30, 2003 |
| K022449 | w.o.m. world of medicine | HYSTEREOSCOPY PUMP HM4 | April 10, 2003 |
| K011876 | circon video | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 | January 8, 2002 |
| K011069 | davol inc., sub. c. r. bard | AQUASENS FLUID MONITORING SYSTEM | August 16, 2001 |
| K000806 | karl storz endoscopy-america | KARL STORZ HYSTEROMAT II | November 30, 2000 |
| K991799 | davol inc., sub. c. r. bard | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO | September 13, 1999 |