FDA 510(k)

VacHeal Negative Pressure Wound Therapy System

K-Number: K254160 · 2026-09-18

Decision Date2026-09-18

Product CodeOKO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VacHeal Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is VacHeal, LLC. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K254160. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VacHeal Negative Pressure Wound Therapy System?

VacHeal Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is VacHeal, LLC. The 510(k) number is K254160.

When did VacHeal Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

VacHeal Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2026-09-18, under 510(k) number K254160.

Who is the listed applicant for VacHeal Negative Pressure Wound Therapy System?

The FDA 510(k) record lists VacHeal, LLC as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for VacHeal Negative Pressure Wound Therapy System is OKO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04042259Delayed Primary Closure Using Negative Pressure Wound TherapyACTIVE_NOT_RECRUITING NCT04618406The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower LimbCOMPLETED NCT04955730NPWT in Patients Undergoing Surgical Procedures for Management of GI MalignanciesCOMPLETED NCT05598398NPWTi on Closure of Chronic Pressure SoresRECRUITING NCT05615844Antibiotic Cement Bead Pouch Versus Negative Pressure Wound TherapyRECRUITING NCT05977816PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy WoundsACTIVE_NOT_RECRUITING

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.