Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vis-U-All Low Temperature Sterilization Pouches

K-Number: K231500 · 2023-08-07

ApplicantSTERIS Corporation
Decision Date2023-08-07
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vis-U-All Low Temperature Sterilization Pouches is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2023-08-07 under approval number K231500. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vis-U-All Low Temperature Sterilization Pouches?

Vis-U-All Low Temperature Sterilization Pouches is a medical device that received FDA 510(k) clearance on 2023-08-07. It is manufactured by STERIS Corporation. The 510(k) number is K231500.

When was Vis-U-All Low Temperature Sterilization Pouches approved by the FDA?

Vis-U-All Low Temperature Sterilization Pouches received FDA 510(k) clearance on 2023-08-07, under approval number K231500.

What company makes Vis-U-All Low Temperature Sterilization Pouches?

Vis-U-All Low Temperature Sterilization Pouches is manufactured by STERIS Corporation.

What is the FDA product code for Vis-U-All Low Temperature Sterilization Pouches?

The FDA product code for Vis-U-All Low Temperature Sterilization Pouches is FRG.

Other Devices by STERIS Corporation

K160912Sterilization Tray K161683SYSTEM 1E Liquid Chemical Sterilant Processing System K160908Vis-U-All Low Temperature Sterilization Pouch/Tubing K160433V-PRO® 1 Plus and V-PRO® maX Low Temperature K160485VERIFY VH2O2 Indicator Tape K152630VERIFY STEAM Integrating Indicator

View all 119 devices →

Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑