Cleared Traditional

K961934 - PURITAN FOAM TIP SWAB MODEL 2197

K961934 is an FDA 510(k) clearance for PURITAN FOAM TIP SWAB MODEL 2197, manufactured by Hardwood Products Co., LP. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K961934 · Hardwood Products Co., LP · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
53d
Days
Class 2
Risk

K961934 is an FDA 510(k) clearance for the PURITAN FOAM TIP SWAB MODEL 2197. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Hardwood Products Co., LP (Guilford, US). The FDA issued a Cleared decision on July 9, 1996 after a review of 53 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.

View all Hardwood Products Co., LP devices

FDA 510(k) Submission Details - K961934

510(k) Number K961934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date July 09, 1996
Days to Decision 53 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 160d · This submission: 53d
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 K961934.
CYTOLOGY BRUSH
K971849 · Team Technologies, Inc. · Jul 1997
PAP BRUSH
K963801 · Young OU Brush Co. · Apr 1997
EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
K963685 · North Eos Industries, Inc. · Oct 1996
DETECT CYTOLOGY BRUSH II
K960469 · Cook Urological, Inc. · Mar 1996
DETECT (TM) CYTOLOGY BRUSH
K933415 · Cook Ob/Gyn · Feb 1994
SPATULA FOR PAP SMEAR COLLECTION
K893229 · Medical Device Inspection Co., Inc. · Feb 1990