PICO Single Use Negative Pressure Wound Therapy System
K-Number: K151436 · 2016-01-28
ApplicantSmith & Nephew Medical, Ltd.
Decision Date2016-01-28
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PICO Single Use Negative Pressure Wound Therapy System is a medical device manufactured by Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2016-01-28 under approval number K151436. 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 PICO Single Use Negative Pressure Wound Therapy System?
PICO Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2016-01-28. It is manufactured by Smith & Nephew Medical, Ltd.. The 510(k) number is K151436.
When was PICO Single Use Negative Pressure Wound Therapy System approved by the FDA?
PICO Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2016-01-28, under approval number K151436.
What company makes PICO Single Use Negative Pressure Wound Therapy System?
PICO Single Use Negative Pressure Wound Therapy System is manufactured by Smith & Nephew Medical, Ltd..
What is the FDA product code for PICO Single Use Negative Pressure Wound Therapy System?
The FDA product code for PICO Single Use Negative Pressure Wound Therapy System 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.