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)

Cardinal Health Sterilization Wrap

K-Number: K161910 · 2017-04-20

ApplicantCardinal Health200, LLC
Decision Date2017-04-20
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cardinal Health Sterilization Wrap is a medical device manufactured by Cardinal Health200, LLC. It received FDA 510(k) clearance on 2017-04-20 under approval number K161910. 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 Cardinal Health Sterilization Wrap?

Cardinal Health Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2017-04-20. It is manufactured by Cardinal Health200, LLC. The 510(k) number is K161910.

When was Cardinal Health Sterilization Wrap approved by the FDA?

Cardinal Health Sterilization Wrap received FDA 510(k) clearance on 2017-04-20, under approval number K161910.

What company makes Cardinal Health Sterilization Wrap?

Cardinal Health Sterilization Wrap is manufactured by Cardinal Health200, LLC.

What is the FDA product code for Cardinal Health Sterilization Wrap?

The FDA product code for Cardinal Health Sterilization Wrap is FRG.

Related Clinical Trials

NCT06355713 Improvement of Symptoms After Removal of the Essure® Contraceptive Implant RECRUITING

Other Devices by Cardinal Health200, LLC

K160339Cardinal Health Isolation Gown K170762Cardinal Health Non-Reinforced Surgical Gown K181174Cardinal Health Sterilization Wrap K192374Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip K182830Cardinal HealthTM Poly-Coated Open-Back Protective Gown K200824Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

View all 14 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.

↑