PICO 14 Single Use Negative Pressure Wound Therapy System
K-Number: K191760 · 2019-12-05
ApplicantSmith & Nephew Medical Limited
Decision Date2019-12-05
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PICO 14 Single Use Negative Pressure Wound Therapy System is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-12-05 under approval number K191760. 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 14 Single Use Negative Pressure Wound Therapy System?
PICO 14 Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-05. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K191760.
When was PICO 14 Single Use Negative Pressure Wound Therapy System approved by the FDA?
PICO 14 Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2019-12-05, under approval number K191760.
What company makes PICO 14 Single Use Negative Pressure Wound Therapy System?
PICO 14 Single Use Negative Pressure Wound Therapy System is manufactured by Smith & Nephew Medical Limited.
What is the FDA product code for PICO 14 Single Use Negative Pressure Wound Therapy System?
The FDA product code for PICO 14 Single Use Negative Pressure Wound Therapy System is OMP.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07475091
Standardizing Swallow Pressure Measurements
NOT_YET_RECRUITING
NCT07260890
Paired Comparison of SVV and PVI Accuracy
COMPLETED
NCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
COMPLETED
NCT05016219
Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
RECRUITING
NCT07235592
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
RECRUITING
Related PubMed Literature
PMID: 41966529
Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load.
Diagnostic microbiology and infectious disease (2026)
PMID: 40942702
Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health.
Sensors (Basel, Switzerland) (2025)
PMID: 40775863
Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship.
Studies in health technology and informatics (2025)
PMID: 40624966
Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing.
Advanced healthcare materials (2025)
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
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.