Cleared Abbreviated

ROVERS SPATULA (K002520) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K002520 · Rovers Medical Devices B.V. · Obstetrics & Gynecology device
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Nov 2000
Decision
90d
Days
Class 2
Risk

K002520 is an FDA 510(k) clearance for the ROVERS SPATULA. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Rovers Medical Devices B.V. (Pasadena, US). The FDA issued a Cleared decision on November 13, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rovers Medical Devices B.V. devices

Submission Details

510(k) Number K002520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date November 13, 2000
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.