Atlas FDA

HHK

42 FDA 510(k) clearances · Product code

84 daysmedian time to decision
244 days90th percentile
42clearances measured

FDA profile

Official device name
Curette, Suction, Endometrial (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1175
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1999: 1 · 2001: 2 · 2003: 1 · 2004: 2 · 2005: 3 · 2006: 2
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
Uterine Aspiration Set (K251882)Gcmedica Enterprise Ltd.(Wuxi)2025-10-16
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (K240434)Li Medical Corporation , Ltd.2024-09-25
CrossGlide ETS Plus (K201952)Crossbay Medical2020-08-05
CrossBay Endometrial Tissue Sampler (ETS) (K192534)Crossbay Medical2020-03-25
DISPOSABLE ENDOMETRIAL SUCTION CURETTE (K102847)Jiangsu Suyun Medical Materials Co., Ltd.2011-04-14
THE PANPAC SUCTION CURETTE (K092982)Panpac Medical Corporation2010-07-26
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (K051294)Femspec LLC2005-12-21
ENDOMETRIAL SAMPLING SYRINGE (K040189)Rocket Medical Plc2004-10-04
MAS WITH OR WITHOUT SYRINGE (K021876)Marina Medical Instruments, Inc.2003-04-08
CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (K020628)Bioteque America, Inc.2002-05-24
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (K001555)Sims Portex , Ltd.2000-08-02
PIPET CURET (K001545)Milex Products, Inc.2000-06-15
FOWLER ENDOCURETTE, MODEL CUR-XXX (K000974)Utah Medical Products, Inc.2000-05-23
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER (K000026)Apple Medical Corp.2000-03-31
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) (K992926)Ri Mos. S.R.L.1999-10-26
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) (K991895)Ri Mos. S.R.L.1999-08-12
ENDOMETRIAL SAMPLER (K990387)U.A. Medical Products, Inc.1999-04-20
SELECTCELLS(TM) MINI (K974819)Select Medical Systems, Inc.1998-03-23
CPR D & C TRAY (K960239)Custom Pack Reliability1996-05-23
SELECTCELLS STANDARD (K954097)Select Medical Systems, Inc.1995-11-21
MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER (K952652)Medscand (Usa), Inc.1995-09-15
CURELLE (K915491)Bioteque Corp.1992-11-04
PIONEER PRO-PUMP (K914220)Pioneer Medical, Inc.1992-03-04
PIONEER PRO-PUMP DUAL CONTROL (K914241)Pioneer Medical, Inc.1992-03-04
PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE (K881456)Laboratoire Ccd C/O Washington Regulatory Services1988-10-14
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE (K875084)Cabot Medical Corp.1988-02-08
ENDOMETRIAL SAMPLER (K872908)Zinnanti Surgical Instruments, Inc.1987-10-20
MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 (K853216)Gyneco, Inc.1986-04-02
ENDOMETRIAL PIPELLE (K854415)Unimar, Inc.1986-03-13
VAKUTAGE (K823080)Weston, Copco, Inc.1982-11-24
MEDEVICES ASPIRATION HOSE (K823006)Berkeley Medevices1982-11-04
U.V.A.C. HANDLER SET (K822382)American Hospital Supply Corp.1982-08-25
UTERINE ASPIRATION CURETTES(RIGID&FLEX) (K812426)Medi-Spec1981-10-08
MENSTRUAL ASPIRATION KITS (K803210)Gynemetrics, Inc.1981-01-28
SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES (K801070)Sherwood Medical Industries1980-07-21
MASTERSON* ENDOMETRIAL BIOPSY KIT (K791765)Codman & Shurtleff, Inc.1979-11-05
MONOJECT ENDOMETRIAL SAMPLING KIT (K790875)Sherwood Medical Co.1979-07-30
BIOPSY KIT 781101, ASPIRATION (K781830)Vista Products, Inc.1978-11-15
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET. (K772121)Smithkline Diagnostics, Inc.1977-11-17
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341 (K771149)C.R. Bard, Inc.1977-07-27
CURETTE, UTERINE, VACUUM ASPIRATING (K770674)American Hospital Supply Corp.1977-04-26
CURETTE, PROPOSED TIS-U-TRAP, METAL (K760264)Milex Products, Inc.1976-10-06

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