Product code HIG
- Device name
- Insufflator, Hysteroscopic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.1700
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026-03-27 |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management Sy... | Hologic, Inc. | 2024-07-25 |
| K210628 | X-FLO Fluid Management System | Thermedx, LLC | 2021-11-04 |
| K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020-07-22 |
| K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018-10-31 |
| K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018-08-03 |
| K173489 | GYN-Pump PH304 | W.O.M. World of Medicine GmbH | 2018-03-28 |
| K172040 | Aquilex Fluid Control System AQL-100S | W.O.M. World of Medicine GmbH | 2018-02-05 |
| K172048 | FluidSmart | Thermedx, LLC | 2017-09-05 |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | Thermedx, LLC | 2014-06-20 |
| K123732 | HYSTEROSCOPY PUMP HM6 | W.O.M. World of Medicine AG | 2013-04-04 |
| K112642 | AQUILEX FLUID CONTROL SYSTEM H112 | W.O.M. World of Medicine AG | 2012-02-06 |
| K110852 | DOLPHIN 3 FLUID MANAGEMENT SYSTEM | Gyrus Acmi, Inc. | 2011-07-19 |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | Thermedx, LLC | 2010-07-23 |
| K031616 | IUR FLUID MANAGEMENT SYSTEM | W.O.M. World of Medicine AG | 2003-08-13 |
| K031213 | AQUASENS FLUID MONITORING SYSTEM | Davol, Inc. | 2003-04-30 |
| K022449 | HYSTEREOSCOPY PUMP HM4 | W.O.M. World of Medicine AG | 2003-04-10 |
| K011876 | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 | Circon Video | 2002-01-08 |
| K011069 | AQUASENS FLUID MONITORING SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 2001-08-16 |
| K000806 | KARL STORZ HYSTEROMAT II | KARL STORZ Endoscopy-America, Inc. | 2000-11-30 |
| K991799 | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO | Davol Inc., Sub. C. R. Bard, Inc. | 1999-09-13 |
| K982867 | HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 | Davol Inc., Sub. C. R. Bard, Inc. | 1999-02-19 |
| K983889 | HYS-SURGIFLATOR 150P | W.O.M. World of Medicine GmbH | 1999-01-14 |
| K970078 | HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 1997-12-11 |
| K971492 | AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR | Bei Medical Systems Co., Inc. | 1997-09-05 |
| K964136 | HYSTERO CO2-PNEU 2221 | Richard Wolf Medical Instruments Corp. | 1997-01-10 |
| K961091 | KARL STORZ MODEL 203020 20 EQUIMAT | KARL STORZ Endoscopy-America, Inc. | 1996-10-03 |
| K934866 | HYS-SURGIMAT | W.O.M. World of Medicine GmbH | 1995-10-20 |
| K933847 | HYS-SURGIFLATOR VP | W.O.M. World of Medicine GmbH | 1995-08-15 |
| K950961 | KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP | KARL STORZ Endoscopy-America, Inc. | 1995-05-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00191506047962 | Asurys™ | BOSTON SCIENTIFIC CORPORATION | 2026-04-03 |
| 00191506023348 | Asurys™ | BOSTON SCIENTIFIC CORPORATION | 2026-04-03 |
| 07613327626407 | ThermaClear | STRYKER CORPORATION | 2025-04-04 |
| 25420045516110 | Fluent Pro Waste Bag | Hologic, Inc. | 2024-10-15 |
| 25420045516134 | Fluent Pro Tissue Trap | Hologic, Inc. | 2024-10-15 |
| 25420045505275 | Fluent Fluid Management System | Hologic, Inc. | 2023-12-19 |
| 25420045507668 | Fluent Fluid Management System | Hologic, Inc. | 2023-12-19 |
| 00850006759163 | Aveta Tissue Catch | MEDITRINA, INC. | 2023-08-16 |
| 00850006759309 | Aveta Smol Disposable Resecting Device, 2.9 mm | MEDITRINA, INC. | 2020-11-16 |
| 00850006759279 | Aveta Disposable Resecting Handset | MEDITRINA, INC. | 2020-09-10 |
| 00850006759293 | Aveta Coral Disposable Hysteroscope | MEDITRINA, INC. | 2020-09-07 |
| 00850006759262 | Aveta Pearl Disposable Hysteroscope | MEDITRINA, INC. | 2020-08-25 |
| 00850006759231 | Aveta Fluid Management Accessory | MEDITRINA, INC. | 2020-08-25 |
| 00850006759149 | Aveta Waste Management Accessory | MEDITRINA, INC. | 2020-05-29 |
| 00850006759002 | Aveta Fluid Management Accessory | MEDITRINA, INC. | 2019-11-28 |
| 00850006759088 | Aveta Disposable Resecting Device 2.9 mm | MEDITRINA, INC. | 2019-11-28 |
| 00850006759095 | Aveta Disposable Resecting Device 3.9 mm | MEDITRINA, INC. | 2019-11-28 |
| 00850006759101 | Aveta Tissue Catch with Suction Tubing | MEDITRINA, INC. | 2019-11-28 |
| 00850006759118 | Aveta Waste Bag. 6L | MEDITRINA, INC. | 2019-11-28 |
| 00850006759057 | Aveta Coral Disposable Hysteroscope | MEDITRINA, INC. | 2019-11-27 |
| 00850006759064 | Aveta Pearl Disposable Hysteroscope | MEDITRINA, INC. | 2019-11-27 |
| 00850006759040 | Aveta Reusable Resecting Handset | MEDITRINA, INC. | 2019-11-26 |
| 10884521744066 | NA | Covidien LP | 2018-08-31 |
| 10884521744059 | NA | Covidien LP | 2018-08-31 |
| 10884521744073 | NA | Covidien LP | 2018-08-31 |
| 07613327055849 | Fluid Safe | STRYKER CORPORATION | 2016-10-14 |
| 00821925030930 | DOLPHIN II | Gyrus ACMI, LLC | 2016-10-13 |
| D6911032224 | Premier | PREMIER DENTAL PRODUCTS COMPANY | 2016-09-16 |
| D6911030842 | Premier | PREMIER DENTAL PRODUCTS COMPANY | 2016-09-16 |
| D6911030840 | Premier | PREMIER DENTAL PRODUCTS COMPANY | 2016-09-16 |