Cleared Abbreviated

GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (K081640) - FDA 510(k) Clearance

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

K081640 · Gimmi GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
329d
Days
Class 2
Risk

K081640 is an FDA 510(k) clearance for the GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Gimmi GmbH (Saint Paul, US). The FDA issued a Cleared decision on May 6, 2009 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5200 - the FDA neurology 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 Gimmi GmbH devices

Submission Details

510(k) Number K081640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2008
Decision Date May 06, 2009
Days to Decision 329 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 148d · This submission: 329d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code HCH Clip, Aneurysm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5200
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 Neurology devices follow this clearance model.