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FDA PRODUCT CODE · CLASS II

OMPNegative Pressure Wound Therapy Powered Suction Pump

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. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4780
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
ImplantLife-sustainingGMP-exemptThird-party review eligible
12
510(K)/PMA CLEARANCES
510k: 12
0
RECALL ENTRIES

Recent clearances

K253263Convatec Limited, Gdc Building · 510k2026-06-24
K253199CG Bio Co., Ltd. · 510k2026-06-23
K260646Smith & Nephew Medical, Ltd. · 510k2026-05-27
K261291Cork Medical · 510k2026-05-21
K254019Bechtel Medical, Inc. · 510k2026-05-04
K253429Genadyne Biotechnologies, Inc. · 510k2026-03-12
K250586Deroyal Industries, Inc. · 510k2025-11-21
K251646Alleva Medical Devices · 510k2025-10-03

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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