Atlas FDA

LKF

87 FDA 510(k) clearances · Product code

154 daysmedian time to decision
418 days90th percentile
87clearances measured

FDA profile

Official device name
Cannula, Manipulator/Injector, Uterine
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 189 · 2022: 100 · 2023: 88 · 2024: 125 · 2025: 96 · 2026: 58
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
FemVue® Controlled Saline-Air Device (FSA-300) (K253403)Femasys, Inc.2025-12-15
RELIEEV HSG Catheter (HSG7FA1) (K252260)Li Medical Corporation , Ltd.2025-11-26
FemVue MINI Saline-Air Device (K242002)Femasys, Inc.2024-11-22
RELIEEV Uterine Manipulator Injector (CUMI 5.0) (K240364)Li Medical Corporation , Ltd.2024-10-16
FemChec Controlled Saline-Air Device (FCD-250) (K241693)Femasys, Inc.2024-09-06
Rejoni Intrauterine Catheter (K222798)Rejoni, Inc.2022-12-16
ALLY II Uterine Positioning System™ (UPS) (K223064)CooperSurgical, Inc.2022-10-28
Uterine ElevatOR PRO with OccludOR Balloon (K220202)The O R Company Pty, Ltd.2022-03-31
DUMI ManipulatOR (K212505)The O R Company Pty, Ltd.2022-01-10
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (K181770)Cook Incorporated2019-03-29
Margolin HSG Cannula, Goldstein Sonohysterography Catheter (K180300)Cook Incorporated2018-10-26
Cook Silicone Balloon HSG Catheter (K180291)Cook Incorporated2018-10-26
Uterine Manipulator (K172846)Beijing Hangtian Kadi Technology R&D Institute2018-06-26
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip (K171604)Cook Incorporated2018-02-15
Unicare System, Unicare Manipulator (K163214)Clearpath Surgical, Inc.2017-02-07
uVue HSG/SHG Catheter (K160217)Cook Incorporated2016-10-06
Ally Uterine Positioning System (K153092)CooperSurgical, Inc.2015-12-21
ManipulatOR PRO, ManipulatOR (K150519)Gynetech Pty. , Ltd.2015-08-19
SonoFlow Sonohysterography and Sonohysterosalpingography Device (K142545)Crossbay Medical, Inc.2015-03-20
Air Bubble Based Infuser (ABBI) (K143415)CooperSurgical, Inc.2015-02-26
VCARE (K142716)Conmed Corporation2015-02-10
MANIPULATOR; MANIPULATOR PRO (K142164)Gynetech Pty. , Ltd.2014-12-17
ALLY UPS (K141523)CooperSurgical, Inc.2014-11-25
CLEARVIEW TOTAL (K131781)Clinical Innovations, LLC2014-05-28
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER (K130758)Kronner Prototypes, Inc.2013-12-11
VIKY UP (K122820)Endocontrol2013-06-18
THE ADVANCE CATHETER FOR HSG AND SIS (K123258)Catheter Research, Inc.2013-01-31
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE (K102898)Panpac Medical Corporation2011-12-15
FEMCHEC PRESSURE MANAGEMET DEVICE (K110993)Femasys, Inc.2011-10-12
FEMVUE SALINE-AIR DEVICE (K110288)Femasys, Inc.2011-04-28
PANPAC HSG CATHETER SET (K092983)Panpac Medical Corporation2010-06-07
H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F (K092969)Sterling Medical, Inc.2010-04-30
FEMVUE CORNUAL BALLOON CATHETER (K100662)Femasys, Inc.2010-04-07
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 (K092984)Panpac Medical Corporation2010-04-07
VCARE DX (K093556)Conmed Corporation2010-03-12
PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 (K092980)Panpac Medical Corporation2010-03-11
EZ HSG CATHETER.FOAMSEAL CATHETER (K083594)Obg Products2009-07-21
FEMVUE(TM) CATHETER SYSTEM (K083690)Femasys, Inc.2009-06-23
PROBE HOLDER SYSTEM (K071405)Intuitive Surgical, Inc.2007-10-09
VCARE RETRACTOR/ELEVATOR (K071907)Conmed Corporation2007-10-05
SALINE/ CONTRAST MEDIA INFUSION CATHETER (K063611)Utah Medical Products, Inc.2007-05-23
WALLACE ARTIFICIAL INSEMINATION CATHETER (K061679)Irvine Scientific Sales Co., Inc.2006-10-13
INTRAUTERINE VENOGRAM NEEDLE SET (K041062)Cook Urological, Inc.2004-10-01
SOFTSEAL HSG CATHETER (K040238)Modern Medical Equipment Mfg., Ltd.2004-06-22
HSG CATHETER SET (K041094)Bioteque America, Inc.2004-06-17
H/S CATHETER SET (K032835)Catheter Research, Inc.2003-12-11
INTRAUTERINE DELIVERY SYSTEM - INJECTOR (K023051)Prosurg, Inc.2002-12-12
UTERINE INJECTOR (K022503)Thomas Medical, Inc.2002-10-25
SIB CATHETER, MODEL 61-7005 (K021272)Ackrad Laboratories2002-05-21
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY (K020954)Ackrad Laboratories2002-04-24
UTERINE INJECTOR (K020292)Catheter Research, Inc.2002-04-17
H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 (K020951)Ackrad Laboratories2002-04-16
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 (K013972)Ackard Laboratories2001-12-17
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 (K013491)A & A Medical, Inc.2001-11-19
SF SH CATHETER, MODEL R65-945 (K013437)A & A Medical, Inc.2001-11-19
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 (K010296)Marina Medical Instruments, Inc.2001-04-11
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 (K010056)A & A Medical, Inc.2001-02-01
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET (K000433)Medical Device Technologies, Inc.2000-06-16
ULTRA CATHETER SET (K001115)Lyco Enterprises, Inc.2000-05-17
UTERINE MANIPULATOR/INJECTOR (K974357)Catheter Research, Inc.1998-02-02
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER (K970492)Ackrad Laboratories1997-04-09
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (K961752)Ackrad Laboratories1996-08-08
CONMED VCARE RETRACTOR/ELEVATOR (K955446)Conmedcorp1996-06-18
ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET (K955508)Cook Urological, Inc.1996-02-26
CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR (K946220)Conmedcorp1995-09-15
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (K953034)Ackrad Laboratories1995-08-29
HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY (K943494)Lyco Enterprises, Inc.1995-07-06
OVAMED FALLOPIAN OSTIAL ACCESS CATHETER (K931167)Ovamed Corp.1995-06-22
LUMIN (K943448)Utah Medical Products, Inc.1995-04-11
OVAMED HSG CATHETER (K931122)Ovamed Corp.1995-01-30
BERNSTEIN(TM) UTERINE MANIPULATOR (K932394)Gm Engineering, Inc.1995-01-26
UTERINE MANIPULATOR/INJECTOR WITH SPRING (K941458)Zinnanti Surgical Instruments, Inc.1995-01-25
UTERINE INJECTOR WITH SPRING (K941457)Zinnanti Surgical Instruments, Inc.1995-01-24
GODAT UTERINE MANIPULATOR INJECTOR (K935023)Ideas For Medicine, Inc.1995-01-04
CONCEPTUS UTERINE CATHETER (K933723)Conceptus, Inc.1994-12-27
CERVICAL CATHETER (K933981)Conceptus, Inc.1994-12-27
CLEARVIEW UTERINE MANIPULATOR (K940681)Clinical Innovations, Inc.1994-07-26
AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR (K930867)United States Surgical, A Division of Tyco Healthc1994-07-25
ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI (K932115)Blairden Precision Instruments, Inc.1994-06-24
DMI UTERINE MOBILIZER/ELEVATOR/CANNULA (K931814)Diversified Medical Instruments, Inc.1994-05-31
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT (K935434)United States Surgical, A Division of Tyco Healthc1994-05-27
KRONNER REINFORCING STYLETTE (K932432)Unimar, Inc.1994-04-12
CANNULA: KAHN, JARCO, CORSON AND RATCHET (K930038)Thomasville Medical Assoc.1994-02-18
MAJOLI UTERINE MANIPULATOR/INJECTOR (K911887)Cook Ob/Gyn1991-07-26
BARD UTERINE MANIPULATOR (K904079)C.R. Bard, Inc.1991-02-07
TWIN BALLOON INJECTOR (K902975)Zinnanti Surgical Instruments, Inc.1990-09-26
CANNULA, PERFUSION, FALLOPIAN TUBE (K772230)J. Sklar Mfg. Co., Inc.1978-01-03

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