Cleared Traditional

K963685 - EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER

K963685 is an FDA 510(k) clearance for EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER, manufactured by North Eos Industries, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K963685 · North Eos Industries, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
38d
Days
Class 2
Risk

K963685 is an FDA 510(k) clearance for the EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by North Eos Industries, Inc. (Taichung Hsien 423, TW). The FDA issued a Cleared decision on October 11, 1996 after a review of 38 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 North Eos Industries, Inc. devices

FDA 510(k) Submission Details - K963685

510(k) Number K963685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date October 11, 1996
Days to Decision 38 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
122d faster than avg
Panel avg: 160d · This submission: 38d
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 13
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K963685.
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