Cleared Traditional

K161600 - Resection Electrodes

K161600 is the FDA 510(k) clearance for Resection Electrodes by Olympus Winter & Ibe GmbH. It is a Class 2 General & Plastic Surgery device (product code JOS) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K161600 · Olympus Winter & Ibe GmbH · General & Plastic Surgery device
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Sep 2016
Decision
89d
Days
Class 2
Risk

K161600 is an FDA 510(k) clearance for the Resection Electrodes. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on September 6, 2016 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Winter & Ibe GmbH devices

Submission Details

510(k) Number K161600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2016
Decision Date September 06, 2016
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOS Electrode, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Gyrus Acmi, Inc.
Dolan Mills

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOS Electrode, Electrosurgical

All 15
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K161600.
REPROCESSED ELECTROSURGICAL ELECTRODE
K012684 · Sterilmed, Inc. · Jan 2002
MEDLINE GROUNDING PAD
K011515 · Medline Industries, Inc. · Jul 2001
ULTRABLATOR ELECTRODE
K993885 · Linvatec Corp. · Feb 2000
CAPSULAR SHRINKAGE ELECTRODE
K991830 · Linvatec Corp. · Aug 1999
STANDARD AND EXTENDED BLADE, NEEDLE AND BALL
K974735 · Aaron Medical Industries · Jun 1998
STANDARD & EXTENDED BLADE/NEEDLE/BALL
K971187 · Aaron Medical Industries · May 1997