Cleared Abbreviated

K012660 - GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES

K012660 is the FDA 510(k) clearance for GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES by Gimmi GmbH. It is a Class 2 Gastroenterology & Urology device (product code FET) cleared through the Abbreviated 510(k) pathway after a 129-day FDA review.

K012660 · Gimmi GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
129d
Days
Class 2
Risk

K012660 is an FDA 510(k) clearance for the GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Gimmi GmbH (Amsterdam, Nh, NL). The FDA issued a Cleared decision on December 20, 2001 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 K012660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date December 20, 2001
Days to Decision 129 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 130d · This submission: 129d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 53
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K012660.
AIDA WITH DICOM AND HL7 INTERFACE
K043324 · KARL STORZ Endoscopy-America, Inc. · Apr 2005
KSEA OPSERVER LAP
K031895 · KARL STORZ Endoscopy-America, Inc. · Sep 2003
1-CCD ENDOCAM 5520 SYSTEM
K023659 · Richard Wolf Medical Instruments Corp. · Jan 2003
KSEA SCB-RUI SCO
K003113 · KARL STORZ Endoscopy-America, Inc. · Mar 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710 · Smith & Nephew, Inc. · Feb 2001
KSEA SCB-RUI
K994348 · KARL STORZ Endoscopy-America, Inc. · Mar 2000