HHK · Class II · 21 CFR 884.1175

FDA Product Code HHK: Curette, Suction, Endometrial (and Accessories)

Leading manufacturers include American Hospital Supply Corp., Ri Mos. S.R.L. and Crossbay Medical.

42
Total
42
Cleared
111d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times: 118d avg (recent)

FDA 510(k) Cleared Curette, Suction, Endometrial (and Accessories) Devices (Product Code HHK)

42 devices
1–24 of 42
Cleared Oct 16, 2025
Uterine Aspiration Set
K251882
Gcmedica Enterprise Ltd.(Wuxi)
Obstetrics & Gynecology · 118d
Cleared Sep 25, 2024
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
K240434
Li Medical Corporation , Ltd.
Obstetrics & Gynecology · 224d
Cleared Aug 05, 2020
CrossGlide ETS Plus
K201952
Crossbay Medical
Obstetrics & Gynecology · 22d
Cleared Mar 25, 2020
CrossBay Endometrial Tissue Sampler (ETS)
K192534
Crossbay Medical
Obstetrics & Gynecology · 191d
Cleared Apr 14, 2011
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
K102847
Jiangsu Suyun Medical Materials Co., Ltd.
Obstetrics & Gynecology · 197d
Cleared Jul 26, 2010
THE PANPAC SUCTION CURETTE
K092982
Panpac Medical Corporation
Obstetrics & Gynecology · 301d
Cleared Dec 21, 2005
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
K051294
Femspec LLC
Obstetrics & Gynecology · 217d
Cleared Oct 04, 2004
ENDOMETRIAL SAMPLING SYRINGE
K040189
Rocket Medical Plc
Obstetrics & Gynecology · 250d
Cleared May 24, 2002
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
K020628
Bioteque America, Inc.
Obstetrics & Gynecology · 87d
Cleared Aug 02, 2000
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
K001555
Sims Portex , Ltd.
Obstetrics & Gynecology · 76d
Cleared Jun 15, 2000
PIPET CURET
K001545
Milex Products, Inc.
Obstetrics & Gynecology · 28d
Cleared May 23, 2000
FOWLER ENDOCURETTE, MODEL CUR-XXX
K000974
Utah Medical Products, Inc.
Obstetrics & Gynecology · 57d
Cleared Mar 31, 2000
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
K000026
Apple Medical Corp.
Obstetrics & Gynecology · 86d
Cleared Oct 26, 1999
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
K992926
Ri Mos. S.R.L.
Obstetrics & Gynecology · 56d
Cleared Aug 12, 1999
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
K991895
Ri Mos. S.R.L.
Obstetrics & Gynecology · 70d
Cleared Apr 20, 1999
ENDOMETRIAL SAMPLER
K990387
U.A. Medical Products, Inc.
Obstetrics & Gynecology · 71d
Cleared Mar 23, 1998
SELECTCELLS(TM) MINI
K974819
Select Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared May 23, 1996
CPR D & C TRAY
K960239
Custom Pack Reliability
Obstetrics & Gynecology · 128d
Cleared Feb 08, 1988
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
K875084
Cabot Medical Corp.
Obstetrics & Gynecology · 61d
Cleared Oct 20, 1987
ENDOMETRIAL SAMPLER
K872908
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 88d
Cleared Aug 25, 1982
U.V.A.C. HANDLER SET
K822382
American Hospital Supply Corp.
Obstetrics & Gynecology · 16d
Cleared Jul 21, 1980
SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
K801070
Sherwood Medical Industries
Obstetrics & Gynecology · 76d
Cleared Nov 05, 1979
MASTERSON* ENDOMETRIAL BIOPSY KIT
K791765
Codman & Shurtleff, Inc.
Obstetrics & Gynecology · 69d
Cleared Jul 30, 1979
MONOJECT ENDOMETRIAL SAMPLING KIT
K790875
Sherwood Medical Co.
Obstetrics & Gynecology · 84d

About Product Code HHK - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code HHK since 1976, with 42 receiving FDA clearance (average review time: 111 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - HHK Product Code

FDA review times for HHK submissions have been consistent, averaging 118 days recently vs 111 days historically.

HHK devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →