Cleared Traditional

Vis-U-All Low Temperature Sterilization Pouch/Tubing (K160908) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160908 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
112d
Days
Class 2
Risk

K160908 is an FDA 510(k) clearance for the Vis-U-All Low Temperature Sterilization Pouch/Tubing. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on July 22, 2016 after a review of 112 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 STERIS Corporation devices

Submission Details

510(k) Number K160908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2016
Decision Date July 22, 2016
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 101
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K160908.
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
Gemini Sterilization Wrap
K152564 · Medline Industries, Inc. · Jul 2016
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016
Gemini Sterilization Wrap
K150698 · Medline Industries, Inc. · Nov 2015