Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
K-Number: K250586 · 2025-11-21
ApplicantDeroyal Industries, Inc.
Decision Date2025-11-21
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory is a medical device manufactured by Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2025-11-21 under approval number K250586. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory?
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Deroyal Industries, Inc.. The 510(k) number is K250586.
When was Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory approved by the FDA?
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory received FDA 510(k) clearance on 2025-11-21, under approval number K250586.
What company makes Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory?
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory is manufactured by Deroyal Industries, Inc..
What is the FDA product code for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory?
The FDA product code for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory is OMP.
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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.