Cleared Traditional

K971849 - CYTOLOGY BRUSH

K971849 is an FDA 510(k) clearance for CYTOLOGY BRUSH, manufactured by Team Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K971849 · Team Technologies, Inc. · Obstetrics & Gynecology device
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Jul 1997
Decision
66d
Days
Class 2
Risk

K971849 is an FDA 510(k) clearance for the CYTOLOGY BRUSH. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Team Technologies, Inc. (Morristown, US). The FDA issued a Cleared decision on July 24, 1997 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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.

FDA 510(k) Submission Details - K971849

510(k) Number K971849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1997
Decision Date July 24, 1997
Days to Decision 66 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 161d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHT Device Classification - Class 2, Special Controls

Product Code HHT Spatula, Cervical, Cytological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HHT Spatula, Cervical, Cytological

All 55
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K971849.
SAFETEX CERVICAL SCRAPER (PLASTIC)
K983428 · Andwin Scientific · Nov 1998
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
K980356 · Canadian Medical Brush, Inc. · Apr 1998
DIGENE CERVICAL BRUSH
K971586 · Digene Corp. · Sep 1997
PAP BRUSH
K963801 · Young OU Brush Co. · Apr 1997
EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
K963685 · North Eos Industries, Inc. · Oct 1996
PURITAN FOAM TIP SWAB MODEL 2197
K961934 · Hardwood Products Co., LP · Jul 1996
K971849 · CYTOLOGY BRUSH
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