Cleared Traditional

STOVALL ENDOMETRIAL BRUSH (K911620) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Cook Ob/Gyn devices

Submission Details

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
Regulatory Context
Review time vs. panel average
1010d slower than avg
Panel avg: 160d · This submission: 1170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.