Cleared Traditional

K963801 - PAP BRUSH

K963801 is an FDA 510(k) clearance for PAP BRUSH, manufactured by Young OU Brush Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K963801 · Young OU Brush Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
198d
Days
Class 2
Risk

K963801 is an FDA 510(k) clearance for the PAP BRUSH. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Young OU Brush Co. (Kyong Buk, KR). The FDA issued a Cleared decision on April 9, 1997 after a review of 198 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Young OU Brush Co. devices

FDA 510(k) Submission Details - K963801

510(k) Number K963801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date April 09, 1997
Days to Decision 198 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
38d slower than avg
Panel avg: 160d · This submission: 198d
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 26
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K963801.
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
K980356 · Canadian Medical Brush, Inc. · Apr 1998
DIGENE CERVICAL BRUSH
K971586 · Digene Corp. · Sep 1997
CYTOLOGY BRUSH
K971849 · Team Technologies, Inc. · Jul 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
DETECT CYTOLOGY BRUSH II
K960469 · Cook Urological, Inc. · Mar 1996