Cleared Traditional

SELECTCELLS STANDARD (K954097) - FDA 510(k) Clearance

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

K954097 · Select Medical Systems, Inc. · Obstetrics & Gynecology device
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Nov 1995
Decision
82d
Days
Class 2
Risk

K954097 is an FDA 510(k) clearance for the SELECTCELLS STANDARD. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Select Medical Systems, Inc. (Williston, US). The FDA issued a Cleared decision on November 21, 1995 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1175 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Select Medical Systems, Inc. devices

Submission Details

510(k) Number K954097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1995
Decision Date November 21, 1995
Days to Decision 82 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 160d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHK Curette, Suction, Endometrial (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1175
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 - HHK Curette, Suction, Endometrial (and Accessories)

All 41
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K954097.
Uterine Aspiration Set
K251882 · Gcmedica Enterprise Ltd.(Wuxi) · Oct 2025
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
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CrossGlide ETS Plus
K201952 · Crossbay Medical · Aug 2020
CrossBay Endometrial Tissue Sampler (ETS)
K192534 · Crossbay Medical · Mar 2020
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K771149 · C.R. Bard, Inc. · Jul 1977