Cleared Traditional

K100275 - WORKING ELEMENT

K100275 is the FDA 510(k) clearance for WORKING ELEMENT by Olympus Winter & Ibe GmbH. It is a Class 2 Gastroenterology & Urology device (product code FAS) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K100275 · Olympus Winter & Ibe GmbH · Gastroenterology & Urology device
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Jul 2010
Decision
150d
Days
Class 2
Risk

K100275 is an FDA 510(k) clearance for the WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECT.... Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Olympus Winter & Ibe GmbH (Center Valley, US). The FDA issued a Cleared decision on July 1, 2010 after a review of 150 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Winter & Ibe GmbH devices

Submission Details

510(k) Number K100275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2010
Decision Date July 01, 2010
Days to Decision 150 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 130d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAS Electrode, Electrosurgical, Active, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - FAS Electrode, Electrosurgical, Active, Urological

All 27
Devices cleared under the same product code (FAS) and FDA review panel - the closest regulatory comparables to K100275.
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
K120418 · Olympus Winter & Ibe GmbH · Jun 2012
GYRUS AMCI PK BUTTON ELECTRODE
K120567 · Gyrus Acmi, Inc. · Jun 2012
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
K102781 · Olympus Winter & Ibe GmbH · Jan 2011
GYRUS ACMI PK BUTTON ELECTRODE
K093181 · Gyrus Acmi, Inc. · Feb 2010
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K031029 · Arthrocare Corp. · Jun 2003
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K022543 · Arthrocare Corp. · Aug 2002