FDA 510(k)

PICO 7Y Single Use Negative Pressure Wound Therapy System

K-Number: K182323 · 2019-01-18

Decision Date2019-01-18

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PICO 7Y Single Use Negative Pressure Wound Therapy System is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-01-18 under approval number K182323. 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 7Y Single Use Negative Pressure Wound Therapy System?

PICO 7Y Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K182323.

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

PICO 7Y Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2019-01-18, under approval number K182323.

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

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

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

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

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Other Devices by Smith & Nephew Medical Limited

K153723ACTICOAT Surgical Dressing K161289DURAFIBER Ag K172521PICO Single Use Negative Pressure Wound Therapy System K172519PICO Single Use Negative Pressure Wound Therapy System K163387PICO Single Use Negative Pressure Wound Therapy System K180698PICO 7 Single Use Negative Pressure Wound Therapy System

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Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, 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.