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)

PICO 7 Single Use Negative Pressure Wound Therapy System

K-Number: K180698 · 2018-08-21

Decision Date2018-08-21
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PICO 7 Single Use Negative Pressure Wound Therapy System is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2018-08-21 under approval number K180698. 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 7 Single Use Negative Pressure Wound Therapy System?

PICO 7 Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2018-08-21. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K180698.

When was PICO 7 Single Use Negative Pressure Wound Therapy System approved by the FDA?

PICO 7 Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2018-08-21, under approval number K180698.

What company makes PICO 7 Single Use Negative Pressure Wound Therapy System?

PICO 7 Single Use Negative Pressure Wound Therapy System is manufactured by Smith & Nephew Medical Limited.

What is the FDA product code for PICO 7 Single Use Negative Pressure Wound Therapy System?

The FDA product code for PICO 7 Single Use Negative Pressure Wound Therapy System is OMP.

Related Clinical Trials

Related PubMed Literature

Other Devices by Smith & Nephew Medical Limited

View all 19 devices →

Related Devices (Code: OMP)

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.