HFE · Class II · 21 CFR 884.1100

FDA Product Code HFE: Brush, Endometrial

Leading manufacturers include Cook Ob/Gyn, Cook Urological, Inc. and Cook Incorporated.

9
Total
9
Cleared
290d
Avg days
1985
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Brush, Endometrial Devices (Product Code HFE)

9 devices
1–9 of 9
Cleared Aug 14, 2024
Utepreva Endometrial Sampler (UP01)
K240595
Utepreva, LLC
Obstetrics & Gynecology · 163d
Cleared May 24, 2017
Tao Brush I.U.M.C. Endometrial Sampler
K170603
Cook Incorporated
Obstetrics & Gynecology · 84d
Cleared Nov 07, 2008
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
K082066
Cook Urological, Inc.
Obstetrics & Gynecology · 108d
Cleared Feb 13, 1995
IUMC ENDOMETRIAL SAMPLER
K941298
Cook Ob/Gyn
Obstetrics & Gynecology · 333d
Cleared Jun 24, 1994
STOVALL ENDOMETRIAL BRUSH
K911620
Cook Ob/Gyn
Obstetrics & Gynecology · 1170d

About Product Code HFE - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code HFE since 1985, with 9 receiving FDA clearance (average review time: 290 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.