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

FDA 510(k)

Cavilon Advanced High Endurance Skin Protectant

K-Number: K153571 · 2016-08-23

Applicant3M Healthcare
Decision Date2016-08-23
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cavilon Advanced High Endurance Skin Protectant is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2016-08-23 under 510(k) number K153571. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cavilon Advanced High Endurance Skin Protectant?

Cavilon Advanced High Endurance Skin Protectant is a medical device that received FDA 510(k) clearance on 2016-08-23. The listed applicant is 3M Healthcare. The 510(k) number is K153571.

When did Cavilon Advanced High Endurance Skin Protectant receive FDA 510(k) clearance?

Cavilon Advanced High Endurance Skin Protectant received FDA 510(k) clearance on 2016-08-23, under 510(k) number K153571.

Who is the listed applicant for Cavilon Advanced High Endurance Skin Protectant?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cavilon Advanced High Endurance Skin Protectant?

The FDA product code for Cavilon Advanced High Endurance Skin Protectant is KMF.

Other records listing 3M Healthcare as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EK1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure MaskK1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face ShieldK1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance SystemK1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S

Related Devices (Code: KMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC

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.

↑