Cleared Traditional

K141412 - STERILUCENT SELF-SEAL STERILIZATION POUCH

K141412 is the FDA 510(k) clearance for STERILUCENT SELF-SEAL STERILIZATION POUCH by Gs Medical Packaging, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K141412 · Gs Medical Packaging, Inc. · General Hospital
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Dec 2014
Decision
188d
Days
Class 2
Risk

K141412 is an FDA 510(k) clearance for the STERILUCENT SELF-SEAL STERILIZATION POUCH. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Gs Medical Packaging, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 3, 2014 after a review of 188 days - an extended review cycle.

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 Gs Medical Packaging, Inc. devices

Submission Details

510(k) Number K141412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2014
Decision Date December 03, 2014
Days to Decision 188 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
59d slower than avg
Panel avg: 129d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 107
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K141412.
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016
Gemini Sterilization Wrap
K150698 · Medline Industries, Inc. · Nov 2015
Gemini Bonded Sterilization Wrap
K143147 · Medline Industries, Inc. · May 2015
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · Kimberly-Clark Corp. · Nov 2014
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
K140487 · STERIS Corporation · Jul 2014
GEMINI STERILZATION WRAP
K113353 · Medline Industries, Inc. · Jan 2013