HHK · Class II · 21 CFR 884.1175

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

Leading manufacturers include American Hospital Supply Corp., Crossbay Medical and C.R. Bard, Inc..

42
Total
42
Cleared
111d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 171d recently vs 108d historically

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 May 23, 2000
FOWLER ENDOCURETTE, MODEL CUR-XXX
K000974
Utah Medical Products, Inc.
Obstetrics & Gynecology · 57d
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
Cleared Nov 17, 1977
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
K772121
Smithkline Diagnostics, Inc.
Obstetrics & Gynecology · 7d
Cleared Jul 27, 1977
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K771149
C.R. Bard, Inc.
Obstetrics & Gynecology · 30d
Cleared Apr 26, 1977
CURETTE, UTERINE, VACUUM ASPIRATING
K770674
American Hospital Supply Corp.
Obstetrics & Gynecology · 15d

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 increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - HHK Product Code

Recent submissions under HHK have taken an average of 171 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.

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