Cleared Traditional

K153025 - Turbett Surgical Container

K153025 is an FDA 510(k) clearance for Turbett Surgical Container, manufactured by Turbett Surgical, LLC. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K153025 · Turbett Surgical, LLC · General Hospital
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Jan 2016
Decision
90d
Days
Class 2
Risk

K153025 is an FDA 510(k) clearance for the Turbett Surgical Container. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Turbett Surgical, LLC (Rochester, US). The FDA issued a Cleared decision on January 14, 2016 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Turbett Surgical, LLC devices

FDA 510(k) Submission Details - K153025

510(k) Number K153025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2015
Decision Date January 14, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 180
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K153025.
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K160908 · STERIS Corporation · Jul 2016
Gemini Sterilization Wrap
K152564 · Medline Industries, Inc. · Jul 2016
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016
Cardinal Health Sterilization Wrap
K151445 · Cardinal Health200, LLC · Dec 2015
Sterisheet Sterilization Wrap
K152291 · Andersen Sterilizers, Inc. · Dec 2015
Gemini Sterilization Wrap
K150698 · Medline Industries, Inc. · Nov 2015