Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System

K-Number: K193185 · 2020-05-04

ApplicantBenq Materials Corporation
Decision Date2020-05-04
Product CodeOKO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is the device name listed in this FDA 510(k) record. The listed applicant is Benq Materials Corporation. It received FDA 510(k) clearance on 2020-05-04 under 510(k) number K193185. 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 Anscare SIMO Negative Pressure Wound Therapy (NPWT) System?

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2020-05-04. The listed applicant is Benq Materials Corporation. The 510(k) number is K193185.

When did Anscare SIMO Negative Pressure Wound Therapy (NPWT) System receive FDA 510(k) clearance?

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2020-05-04, under 510(k) number K193185.

Who is the listed applicant for Anscare SIMO Negative Pressure Wound Therapy (NPWT) System?

The FDA 510(k) record lists Benq Materials Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anscare SIMO Negative Pressure Wound Therapy (NPWT) System?

The FDA product code for Anscare SIMO Negative Pressure Wound Therapy (NPWT) 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_RECRUITINGNCT04618406The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower LimbCOMPLETEDNCT04955730NPWT in Patients Undergoing Surgical Procedures for Management of GI MalignanciesCOMPLETEDNCT05615844Antibiotic Cement Bead Pouch Versus Negative Pressure Wound TherapyRECRUITINGNCT05977816PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy WoundsACTIVE_NOT_RECRUITINGNCT06025253PINTA - Prophylactic Incisional Negative Pressure Therapy for Major AmputationsRECRUITING

Other records listing Benq Materials Corporation as applicant

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.

K242056miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus

Related Devices (Code: OKO)

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.

K251156NPsealGuard Medical, Inc.K250708NPsealGuard Medical, Inc.K241522NPseal (20 and 25)Guard Medical, Inc.K240244NPseal (Small, Medium, Large)Guard Medical, Inc.K212971NPsealGuard Medical, Inc.K211130NPsealGuard Medical, Inc.

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.

↑