Insufflator, Hysteroscopic
FDA product code HIG · 56 cleared devices
Class 2
Obstetrics/Gynecology
- Regulation
- 21 CFR 884.1700
- Review panel
- OB
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1984-09-21 – 2026-07-16
HIG
2026-07-16
HIG
2026-03-27
Asurys Fluid Management System
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HIG
2024-07-25
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 System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)
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HIG
2021-11-04
X-FLO Fluid Management System
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HIG
2020-07-22
Endomat Select, IBS Shaver Software, License
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HIG
2018-10-31
Endomat Select
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HIG
2018-08-03
Fluent Fluid Management System
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HIG
2018-03-28
GYN-Pump PH304
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HIG
2018-02-05
Aquilex Fluid Control System AQL-100S
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HIG
2017-09-05
FluidSmart
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HIG
2013-04-04
HYSTEROSCOPY PUMP HM6
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HIG
2012-02-06
AQUILEX FLUID CONTROL SYSTEM H112
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HIG
2011-07-19
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
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HIG
2010-07-23
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
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HIG
2003-08-13
IUR FLUID MANAGEMENT SYSTEM
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HIG
2003-04-30
AQUASENS FLUID MONITORING SYSTEM
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HIG
2003-04-10
HYSTEREOSCOPY PUMP HM4
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HIG
2002-01-08
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
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HIG
2001-08-16
AQUASENS FLUID MONITORING SYSTEM
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HIG
2000-11-30
KARL STORZ HYSTEROMAT II
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HIG
1999-09-13
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
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HIG
1999-02-19
HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000
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HIG
1999-01-14
HYS-SURGIFLATOR 150P
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HIG
1997-12-11
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
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HIG
1997-09-05
AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR
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HIG
1997-01-10
HYSTERO CO2-PNEU 2221
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HIG
1996-10-03
KARL STORZ MODEL 203020 20 EQUIMAT
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HIG
1995-10-20
HYS-SURGIMAT
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HIG
1995-08-15
HYS-SURGIFLATOR VP
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HIG
1995-05-25
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
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HIG
1995-04-19
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
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HIG
1995-04-11
HYS-SURGIFLATOR
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HIG
1995-01-24
THE KARL STORZ HAMOU ENDOMAT
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HIG
1994-12-30
BARD HYSTERO-FLO II PUMP
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HIG
1994-12-29
CONCEPT UNIVERSAL PUMP SYSTEM
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HIG
1994-12-15
HYSTEROMAT(TM) 3700
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HIG
1994-10-17
HYSTEROMED 100
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HIG
1994-03-25
WOM HYSTEROFLATOR OP
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HIG
1994-01-24
7-510-25 HYSTEROMED TUBING KIT
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HIG
1993-09-24
INSUFFLATOR TUBING KIT
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HIG
1991-12-18
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
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HIG
1991-11-21
HYSTEROFLATOR 1500
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HIG
1991-09-20
LM-100/200LOW FLOW INSUFFLATOR
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HIG
1991-04-29
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
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HIG
1991-02-28
GYN-1500 HYSTEROSCOPIC INUFFLATOR
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HIG
1990-10-10
DAVOL SCOPE IRRIGATION SYSTEM
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HIG
1990-05-21
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
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HIG
1990-03-05
REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
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HIG
1989-12-19
HUI MINI-FLEX
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HIG
1989-12-14
HYSTEROFLATOR 2001
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HIG
1989-06-16
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
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HIG
1989-03-17
UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET
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HIG
1988-07-15
ACKRAD H/S PROCEDURE TRAY
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HIG
1988-02-26
DECHERNEY HYSTEROSCOPY PUMP SYSTEM
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HIG
1987-11-16
INSUFFLATOR TUBING
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HIG
1984-09-21
AXCAN UTERINE SUCCION INJECTOR
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