Cleared Traditional

K102158 - SIGMA STERILIZATION POUCH & ROLL

K102158 is an FDA 510(k) clearance for SIGMA STERILIZATION POUCH & ROLL, manufactured by Sigma Medical Supplies Corp.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K102158 · Sigma Medical Supplies Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
368d
Days
Class 2
Risk

K102158 is an FDA 510(k) clearance for the SIGMA STERILIZATION POUCH & ROLL. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Sigma Medical Supplies Corp. (Kaohsiung, TW). The FDA issued a Cleared decision on August 2, 2011 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sigma Medical Supplies Corp. devices

FDA 510(k) Submission Details - K102158

510(k) Number K102158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2010
Decision Date August 02, 2011
Days to Decision 368 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
239d slower than avg
Panel avg: 129d · This submission: 368d
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 165
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K102158.
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K093493 · Aesculap, Inc. · Jul 2010
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K092167 · Kimberly-Clark Corp. · Nov 2009