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OKO — Negative Pressure Wound Therapy Non-Powered Suction Apparatus Class II

FDA Device Classification

FDA product code OKO covers "Negative Pressure Wound Therapy Non-Powered Suction Apparatus", a Class II medical device regulated under 21 CFR 878.4683. Submissions are reviewed by the General, Plastic Surgery panel. At least 18 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
OKO
Device Class
Class II
Regulation Number
878.4683
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K254160vachealVacHeal Negative Pressure Wound Therapy SystemSeptember 18, 2026
K251156guard medicalNPsealMay 15, 2025
K250708guard medicalNPsealApril 8, 2025
K241522guard medicalNPseal (20 and 25)August 15, 2024
K240244guard medicalNPseal (Small, Medium, Large)February 29, 2024
K212971guard medicalNPsealFebruary 10, 2022
K211130guard medicalNPsealMay 14, 2021
K200305guard medicalNPsealMay 26, 2020
K193185benq materials corporationAnscare SIMO Negative Pressure Wound Therapy (NPWT) SystemMay 4, 2020
K151710spiracurSNaP Wound Care SystemNovember 19, 2015
K142272spiracurSNaP Wound Care SystemNovember 25, 2014
K132080spiracurSNAP WOUND CARE SYSTEMMarch 12, 2014
K133137spiracurCISNAP CLOSED INCISION SYSTEMFebruary 25, 2014
K113032spiracurSNAP WOUND CARE SYSTEMDecember 1, 2011
K112341spiracurSNAP WOUND CARE SYSTEMAugust 29, 2011
K111393spiracurSNAP (R) WOUND CARE SYSTEMJuly 28, 2011
K111006spiracurCI-SNAP WOUND CARE SYSTEMJuly 21, 2011
DEN080011spiracurSNAP WOUND CARE DEVICEAugust 7, 2009

FDA data resources