Atlas FDA

HIG

57 FDA 510(k) clearances · Product code

178 daysmedian time to decision
602 days90th percentile
57clearances measured

FDA profile

Official device name
Insufflator, Hysteroscopic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1700
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 130 · 2022: 66 · 2023: 33 · 2024: 45 · 2025: 46 · 2026: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Endomat Select (UP220) (K261706)KARL STORZ SE & CO. KG2026-07-16
Asurys Fluid Management System (K251273)Boston Scientific Corporation2026-03-27
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) (K240886)Hologic, Inc.2024-07-25
X-FLO Fluid Management System (K210628)Thermedx, LLC2021-11-04
Endomat Select, IBS Shaver Software, License (K201355)Karl Storz SE & CO. KG2020-07-22
Endomat Select (K180735)Karl Storz SE & CO. KG2018-10-31
Fluent Fluid Management System (K180825)Hologic, Inc.2018-08-03
GYN-Pump PH304 (K173489)W.O.M. World of Medicine GmbH2018-03-28
Aquilex Fluid Control System AQL-100S (K172040)W.O.M. World of Medicine GmbH2018-02-05
FluidSmart (K172048)Thermedx, LLC2017-09-05
THERMEDX FLUID MANAGMENT SYSTEM (K133799)Thermedx, LLC2014-06-20
HYSTEROSCOPY PUMP HM6 (K123732)W.O.M. World of Medicine AG2013-04-04
AQUILEX FLUID CONTROL SYSTEM H112 (K112642)W.O.M. World of Medicine AG2012-02-06
DOLPHIN 3 FLUID MANAGEMENT SYSTEM (K110852)Gyrus Acmi, Inc.2011-07-19
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 (K091939)Thermedx, LLC2010-07-23
IUR FLUID MANAGEMENT SYSTEM (K031616)W.O.M. World of Medicine AG2003-08-13
AQUASENS FLUID MONITORING SYSTEM (K031213)Davol, Inc.2003-04-30
HYSTEREOSCOPY PUMP HM4 (K022449)W.O.M. World of Medicine AG2003-04-10
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 (K011876)Circon Video2002-01-08
AQUASENS FLUID MONITORING SYSTEM (K011069)Davol Inc., Sub. C. R. Bard, Inc.2001-08-16
KARL STORZ HYSTEROMAT II (K000806)KARL STORZ Endoscopy-America, Inc.2000-11-30
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO (K991799)Davol Inc., Sub. C. R. Bard, Inc.1999-09-13
HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 (K982867)Davol Inc., Sub. C. R. Bard, Inc.1999-02-19
HYS-SURGIFLATOR 150P (K983889)W.O.M. World of Medicine GmbH1999-01-14
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM (K970078)Davol Inc., Sub. C. R. Bard, Inc.1997-12-11
AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR (K971492)Bei Medical Systems Co., Inc.1997-09-05
HYSTERO CO2-PNEU 2221 (K964136)Richard Wolf Medical Instruments Corp.1997-01-10
KARL STORZ MODEL 203020 20 EQUIMAT (K961091)KARL STORZ Endoscopy-America, Inc.1996-10-03
HYS-SURGIMAT (K934866)W.O.M. World of Medicine GmbH1995-10-20
HYS-SURGIFLATOR VP (K933847)W.O.M. World of Medicine GmbH1995-08-15
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP (K950961)KARL STORZ Endoscopy-America, Inc.1995-05-25
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP (K941743)Cabot Medical Corp.1995-04-19
HYS-SURGIFLATOR (K924523)W.O.M. World of Medicine GmbH1995-04-11
THE KARL STORZ HAMOU ENDOMAT (K936231)Karl Storz Endoscopy1995-01-24
BARD HYSTERO-FLO II PUMP (K933384)Davol Inc., Sub. C. R. Bard, Inc.1994-12-30
CONCEPT UNIVERSAL PUMP SYSTEM (K933873)Linvatec Corp.1994-12-29
HYSTEROMAT(TM) 3700 (K921871)F.M. Wiest USA, Inc.1994-12-15
HYSTEROMED 100 (K930912)Northgate Technologies, Inc.1994-10-17
WOM HYSTEROFLATOR OP (K922632)W.O.M. GmbH1994-03-25
7-510-25 HYSTEROMED TUBING KIT (K931606)Nortech1994-01-24
INSUFFLATOR TUBING KIT (K922197)O.R. Concepts, Inc.1993-09-24
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR (K912498)KARL STORZ Endoscopy-America, Inc.1991-12-18
HYSTEROFLATOR 1500 (K911844)F.M. Wiest USA, Inc.1991-11-21
LM-100/200LOW FLOW INSUFFLATOR (K912789)Leisegang Medical, Inc.1991-09-20
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR (K905495)Frigitronics, Inc.1991-04-29
GYN-1500 HYSTEROSCOPIC INUFFLATOR (K905706)Circon Acmi1991-02-28
DAVOL SCOPE IRRIGATION SYSTEM (K901288)C.R. Bard, Inc.1990-10-10
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 (K900908)Zimmer, Inc.1990-05-21
REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA (K894259)Washington Regulatory Services1990-03-05
HUI MINI-FLEX (K895659)Unimar, Inc.1989-12-19
HYSTEROFLATOR 2001 (K895907)Cabot Medical Corp.1989-12-14
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE (K892001)Dexide, Inc.1989-06-16
UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET (K891028)Zinnanti Surgical Instruments, Inc.1989-03-17
ACKRAD H/S PROCEDURE TRAY (K881680)Ackrad Laboratories1988-07-15
DECHERNEY HYSTEROSCOPY PUMP SYSTEM (K873527)Cabot Medical Corp.1988-02-26
INSUFFLATOR TUBING (K872860)Medline Industries, Inc.1987-11-16
AXCAN UTERINE SUCCION INJECTOR (K842943)Axcan Scientific Corp.1984-09-21

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Every clearance here is in the API, with alerts when new ones post.