510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OKOClass II

Negative Pressure Wound Therapy Non-Powered Suction Apparatus

21 CFR 878.4683 / General, Plastic Surgery
FDA source (opens on fda.gov)

OKO is the FDA product code for Negative Pressure Wound Therapy Non-Powered Suction Apparatus, a class II device type, regulated under 21 CFR 878.4683. FDA's definition for this code reads: "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". As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OKO
Device name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
FDA 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.
Regulation
21 CFR 878.4683
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
0

Clearances, product code OKO

By decision year
18 clearances under product code OKO with a decision year between 2009 and 2026, 2011 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code OKO by decision year
YearClearances
20091
20114
20143
20151
20202
20211
20221
20242
20252
20261

Applicants with the most clearances

Product code OKO
Applicants holding the most 510(k) clearances under product code OKO
ApplicantClearances
Spiracur, Inc.9
Guard Medical, Inc.7
Benq Materials Corporation1
VacHeal, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code