Cleared Traditional

K062433 - DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM

K062433 is an FDA 510(k) clearance for DIAMICS CERCOL CERVICAL SAMPLE COLLECTO..., manufactured by Diamics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K062433 · Diamics, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
207d
Days
Class 2
Risk

K062433 is an FDA 510(k) clearance for the DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Diamics, Inc. (Novato, US). The FDA issued a Cleared decision on March 16, 2007 after a review of 207 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.

FDA 510(k) Submission Details - K062433

510(k) Number K062433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2006
Decision Date March 16, 2007
Days to Decision 207 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
46d slower than avg
Panel avg: 161d · This submission: 207d
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 67
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K062433.
PAPCONE
K083012 · Otto Bock Pur Life Science GmbH · Apr 2009
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K081522 · Bio Nuclear Diagnostics, Inc. · Dec 2008
SOFTPAP CERVICAL CELL COLLECTOR
K072381 · Cytocore, Inc. · Jan 2008
CERVEX-BRUSH COMBI
K043369 · Rovers Medical Devices B.V. · Feb 2005
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
K042527 · Medical Action Industries, Inc. · Nov 2004
DRG SOFTRELEASE
K041018 · Doctor'S Research Group, Inc. · Oct 2004
K062433 · DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
Download PDF FDA Summary Diamics, Inc.