Product Code: HHK FDA class 2 21 CFR 884.1175

Curette, Suction, Endometrial (And Accessories)

Obstetrics/Gynecology

The Endometrial Suction Curette (and accessories) is a device used to aspirate and collect endometrial tissue from the uterine lining for histopathological examination, typically performed as an outpatient procedure for the evaluation of abnormal uterine bleeding or endometrial pathology. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHK, regulated under 21 CFR 884.1175, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: HHK
Device Class: FDA class 2
Regulation Number: 884.1175
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251882	Uterine Aspiration Set	Oct 16, 2025	Substantially Equivalent	Gcmedica Enterprise Ltd.(Wuxi)
K240434	RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)	Sep 25, 2024	Substantially Equivalent	Li Medical Corporation , Ltd.
K201952	CrossGlide ETS Plus	Aug 05, 2020	Substantially Equivalent	Crossbay Medical
K192534	CrossBay Endometrial Tissue Sampler (ETS)	Mar 25, 2020	Substantially Equivalent	Crossbay Medical
K102847	DISPOSABLE ENDOMETRIAL SUCTION CURETTE	Apr 14, 2011	Substantially Equivalent	Jiangsu Suyun Medical Materials Co., Ltd.
K092982	THE PANPAC SUCTION CURETTE	Jul 26, 2010	Substantially Equivalent	Panpac Medical Corporation
K051294	FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1	Dec 21, 2005	Substantially Equivalent	Femspec LLC
K040189	ENDOMETRIAL SAMPLING SYRINGE	Oct 04, 2004	Substantially Equivalent	Rocket Medical Plc
K021876	MAS WITH OR WITHOUT SYRINGE	Apr 08, 2003	Substantially Equivalent	Marina Medical Instruments, Inc.
K020628	CURELLE, PREFERRED CURELLE, CUTEQ 2.5	May 24, 2002	Substantially Equivalent	Bioteque America, Inc.
K001555	SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26	Aug 02, 2000	Substantially Equivalent	Sims Portex , Ltd.
K001545	PIPET CURET	Jun 15, 2000	Substantially Equivalent	Milex Products, Inc.
K000974	FOWLER ENDOCURETTE, MODEL CUR-XXX	May 23, 2000	Substantially Equivalent	Utah Medical Products, Inc.
K000026	APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER	Mar 31, 2000	Substantially Equivalent	Apple Medical Corp.
K992926	GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)	Oct 26, 1999	Substantially Equivalent	Ri Mos. S.R.L.
K991895	RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)	Aug 12, 1999	Substantially Equivalent	Ri Mos. S.R.L.
K990387	ENDOMETRIAL SAMPLER	Apr 20, 1999	Substantially Equivalent	U.A. Medical Products, Inc.
K974819	SELECTCELLS(TM) MINI	Mar 23, 1998	Substantially Equivalent	Select Medical Systems, Inc.
K960239	CPR D & C TRAY	May 23, 1996	Substantially Equivalent	Custom Pack Reliability
K954097	SELECTCELLS STANDARD	Nov 21, 1995	Substantially Equivalent	Select Medical Systems, Inc.
K952652	MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER	Sep 15, 1995	Substantially Equivalent	Medscand (Usa), Inc.
K915491	CURELLE	Nov 04, 1992	Substantially Equivalent	Bioteque Corp.
K914241	PIONEER PRO-PUMP DUAL CONTROL	Mar 04, 1992	Substantially Equivalent	Pioneer Medical, Inc.
K914220	PIONEER PRO-PUMP	Mar 04, 1992	Substantially Equivalent	Pioneer Medical, Inc.
K881456	PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE	Oct 14, 1988	Substantially Equivalent	Laboratoire Ccd C/O Washington Regulatory Services
K875084	CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE	Feb 08, 1988	Substantially Equivalent	Cabot Medical Corp.
K872908	ENDOMETRIAL SAMPLER	Oct 20, 1987	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K853216	MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4	Apr 02, 1986	Substantially Equivalent	Gyneco, Inc.
K854415	ENDOMETRIAL PIPELLE	Mar 13, 1986	Substantially Equivalent	Unimar, Inc.
K823080	VAKUTAGE	Nov 24, 1982	Substantially Equivalent	Weston, Copco, Inc.
K823006	MEDEVICES ASPIRATION HOSE	Nov 04, 1982	Substantially Equivalent	Berkeley Medevices
K822382	U.V.A.C. HANDLER SET	Aug 25, 1982	Substantially Equivalent	American Hospital Supply Corp.
K812426	UTERINE ASPIRATION CURETTES(RIGID&FLEX)	Oct 08, 1981	Substantially Equivalent	Medi-Spec
K803210	MENSTRUAL ASPIRATION KITS	Jan 28, 1981	Substantially Equivalent	Gynemetrics, Inc.
K801070	SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES	Jul 21, 1980	Substantially Equivalent	Sherwood Medical Industries
K791765	MASTERSON* ENDOMETRIAL BIOPSY KIT	Nov 05, 1979	Substantially Equivalent	Codman & Shurtleff, Inc.
K790875	MONOJECT ENDOMETRIAL SAMPLING KIT	Jul 30, 1979	Substantially Equivalent	Sherwood Medical Co.
K781830	BIOPSY KIT 781101, ASPIRATION	Nov 15, 1978	Substantially Equivalent	Vista Products, Inc.
K772121	ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.	Nov 17, 1977	Substantially Equivalent	Smithkline Diagnostics, Inc.
K771149	ENDOMETRIAL ASPIRATION BIOSPY KIT 182341	Jul 27, 1977	Substantially Equivalent	C.R. Bard, Inc.
K770674	CURETTE, UTERINE, VACUUM ASPIRATING	Apr 26, 1977	Substantially Equivalent	American Hospital Supply Corp.
K760264	CURETTE, PROPOSED TIS-U-TRAP, METAL	Oct 06, 1976	Substantially Equivalent	Milex Products, Inc.