Cleared Abbreviated

SIGMA Sterilization Pouch and Roll (K202462) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K202462 · Sigma Medical Supplies Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
239d
Days
Class 2
Risk

K202462 is an FDA 510(k) clearance for the SIGMA Sterilization Pouch and Roll. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Sigma Medical Supplies Corporation (New Taipei City, TW). The FDA issued a Cleared decision on April 23, 2021 after a review of 239 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sigma Medical Supplies Corporation devices

Submission Details

510(k) Number K202462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2020
Decision Date April 23, 2021
Days to Decision 239 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 129d · This submission: 239d
Pathway characteristics
Standards-based clearance path.

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 Consultant

Sen MU Technology Co., Ltd.
Uta Shih

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 - FRG Wrap, Sterilization

All 89
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K202462.
SterileRight sterilization pouch and roll
K212338 · Sterileright Packaging Mfg., Inc. · Nov 2021
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
K212198 · Plasmapp Co,., Ltd. · Oct 2021
Turbett Instrument Pod
K202593 · Turbett Surgical, Inc. · May 2021
Sterisheet Sterilization Wrap
K200335 · Andersen Sterilizers, Inc. · Nov 2020
Tyvek Sterilization Pouches with Chevron Seal
K200336 · Andersen Sterilizers, Inc. · Nov 2020
Turbett Instrument Pod
K200240 · Turbett Surgical, Inc. · Apr 2020