Cleared Traditional

K911620 - STOVALL ENDOMETRIAL BRUSH

K911620 is an FDA 510(k) clearance for STOVALL ENDOMETRIAL BRUSH, manufactured by Cook Ob/Gyn. The device is a Class 2 Obstetrics & Gynecology device with product code HFE cleared through the Traditional 510(k) pathway after a 1170-day FDA review.

K911620 · Cook Ob/Gyn · Obstetrics & Gynecology device
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Jun 1994
Decision
1170d
Days
Class 2
Risk

K911620 is an FDA 510(k) clearance for the STOVALL ENDOMETRIAL BRUSH. Classified as Brush, Endometrial (product code HFE), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on June 24, 1994 after a review of 1170 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1100 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K911620

510(k) Number K911620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date June 24, 1994
Days to Decision 1170 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1009d slower than avg
Panel avg: 161d · This submission: 1170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFE Device Classification - Class 2, Special Controls

Product Code HFE Brush, Endometrial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFE Brush, Endometrial

All 8
Devices cleared under the same product code (HFE) and FDA review panel - the closest regulatory comparables to K911620.
MATRIXBRUSH ENDOMETRIAL SAMPLER
K112763 · Post Oak Innovations, Inc. · Jun 2012
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
K082066 · Cook Urological, Inc. · Nov 2008
IUMC ENDOMETRIAL SAMPLER
K941298 · Cook Ob/Gyn · Feb 1995
ENDOBRUSH(TM) DEVICE
K897070 · Intl. Cytobrush, Inc. · Sep 1990
ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER
K881220 · Laboratoire Ccd C/O Washington Regulatory Services · Jun 1988
ENDOCYTE
K843941 · Gyneco, Inc. · Feb 1985
K911620 · STOVALL ENDOMETRIAL BRUSH
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