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FDA 510(k)

Tegaderm Post-Op Transparent Antimicrobial Dressing

K-Number: K251866 · 2025-10-10

ApplicantSolventum US, LLC
Decision Date2025-10-10
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Tegaderm Post-Op Transparent Antimicrobial Dressing is a medical device manufactured by Solventum US, LLC. It received FDA 510(k) clearance on 2025-10-10 under approval number K251866. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tegaderm Post-Op Transparent Antimicrobial Dressing?

Tegaderm Post-Op Transparent Antimicrobial Dressing is a medical device that received FDA 510(k) clearance on 2025-10-10. It is manufactured by Solventum US, LLC. The 510(k) number is K251866.

When was Tegaderm Post-Op Transparent Antimicrobial Dressing approved by the FDA?

Tegaderm Post-Op Transparent Antimicrobial Dressing received FDA 510(k) clearance on 2025-10-10, under approval number K251866.

What company makes Tegaderm Post-Op Transparent Antimicrobial Dressing?

Tegaderm Post-Op Transparent Antimicrobial Dressing is manufactured by Solventum US, LLC.

What is the FDA product code for Tegaderm Post-Op Transparent Antimicrobial Dressing?

The FDA product code for Tegaderm Post-Op Transparent Antimicrobial Dressing is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT05741866 Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) COMPLETED NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT07066254 The Mepilex Cesarean Delivery Trial NOT_YET_RECRUITING

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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.

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