FDA.report

510(k) K250708

Device
NPseal
Applicant
Guard Medical, Inc.
510(k) number
K250708
Product code
OKO
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-08
Date received
2025-03-10
Regulation
878.4683
Classification name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Machiel van der Leest
Address
1221 Brickell Ave. Suite 900 Miami FL US 33131 33131

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code OKO

510(k)DeviceApplicantDecision date
K251156NPsealGuard Medical, Inc.2025-05-15
K241522NPseal (20 and 25)Guard Medical, Inc.2024-08-15
K240244NPseal (Small, Medium, Large)Guard Medical, Inc.2024-02-29
K212971NPsealGuard Medical, Inc.2022-02-10
K211130NPsealGuard Medical, Inc.2021-05-14
K200305NPsealGuard Medical, Inc.2020-05-26
K193185Anscare SIMO Negative Pressure Wound Therapy (NPWT) SystemBenq Materials Corporation2020-05-04
K151710SNaP Wound Care SystemSpiracur, Inc.2015-11-19
K142272SNaP Wound Care SystemSpiracur, Inc.2014-11-25
K132080SNAP WOUND CARE SYSTEMSpiracur, Inc.2014-03-12
K133137CISNAP CLOSED INCISION SYSTEMSpiracur, Inc.2014-02-25
K113032SNAP WOUND CARE SYSTEMSpiracur, Inc.2011-12-01
K112341SNAP WOUND CARE SYSTEMSpiracur, Inc.2011-08-29
K111393SNAP (R) WOUND CARE SYSTEMSpiracur, Inc.2011-07-28
K111006CI-SNAP WOUND CARE SYSTEMSpiracur, Inc.2011-07-21