Cleared Traditional

K151104 - OTELO LL

K151104 is the FDA 510(k) clearance for OTELO LL by Spineart. It is a Class 1 General & Plastic Surgery device (product code GAD) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K151104 · Spineart · General & Plastic Surgery device
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Jan 2016
Decision
257d
Days
Class 1
Risk

K151104 is an FDA 510(k) clearance for the OTELO LL. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on January 6, 2016 after a review of 257 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K151104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2015
Decision Date January 06, 2016
Days to Decision 257 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
142d slower than avg
Panel avg: 115d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GAD Retractor

All 34
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K151104.
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · Medtronic, Inc. · Oct 2013
QUADRANT RETRACTOR SYSTEM
K043602 · Medtronic Sofamor Danek · Feb 2005
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992
ROLLET RETRACTOR
K891892 · Zinnanti Surgical Instruments, Inc. · Apr 1989
KIRSCHNER RETRACTOR
K891031 · Zinnanti Surgical Instruments, Inc. · Apr 1989
SURGICAL RETRACTORS
K890247 · Kinetic Medical Products · Jan 1989