Cleared Abbreviated

Sterilization Pouch/Roll Made with Tyvek (K180672) - FDA 510(k) Clearance

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

K180672 · Sigma Medical Supplies Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
84d
Days
Class 2
Risk

K180672 is an FDA 510(k) clearance for the Sterilization Pouch/Roll Made with Tyvek. 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 June 6, 2018 after a review of 84 days - a notably fast clearance 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 K180672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date June 06, 2018
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 K180672.
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183297 · STERIS Corporation · Jan 2019
Cardinal Health Sterilization Wrap
K181174 · Cardinal Health200, LLC · Dec 2018
BH Sterilization Pouch
K172280 · Bh Medical Products Co., Ltd. · Aug 2018
SIGMA Sterilization Pouch and Roll
K180661 · Sigma Medical Supplies Corp. · Jun 2018
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K172749 · STERIS Corporation · Feb 2018
Gemini Sterilization Wrap
K162993 · Medline Industries, Inc. · Jun 2017