Cleared Traditional

K954097 - SELECTCELLS STANDARD

K954097 is an FDA 510(k) clearance for SELECTCELLS STANDARD, manufactured by Select Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K954097 · Select Medical Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K954097

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.

HHK Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K954097.
ENDOMETRIAL SAMPLER
K990387 · U.A. Medical Products, Inc. · Apr 1999
SELECTCELLS(TM) MINI
K974819 · Select Medical Systems, Inc. · Mar 1998
CPR D & C TRAY
K960239 · Custom Pack Reliability · May 1996
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
K875084 · Cabot Medical Corp. · Feb 1988
ENDOMETRIAL SAMPLER
K872908 · Zinnanti Surgical Instruments, Inc. · Oct 1987
U.V.A.C. HANDLER SET
K822382 · American Hospital Supply Corp. · Aug 1982