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)

MyNeWT Negative Pressure Wound Therapy System

K-Number: K161432 · 2017-02-08

ApplicantStortford Medical, LLC
Decision Date2017-02-08
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MyNeWT Negative Pressure Wound Therapy System is a medical device manufactured by Stortford Medical, LLC. It received FDA 510(k) clearance on 2017-02-08 under approval number K161432. 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 MyNeWT Negative Pressure Wound Therapy System?

MyNeWT Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-02-08. It is manufactured by Stortford Medical, LLC. The 510(k) number is K161432.

When was MyNeWT Negative Pressure Wound Therapy System approved by the FDA?

MyNeWT Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-02-08, under approval number K161432.

What company makes MyNeWT Negative Pressure Wound Therapy System?

MyNeWT Negative Pressure Wound Therapy System is manufactured by Stortford Medical, LLC.

What is the FDA product code for MyNeWT Negative Pressure Wound Therapy System?

The FDA product code for MyNeWT 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)

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.

↑