Negative Pressure Wound Therapy Non-powered Suction Apparatus
General, Plastic Surgery · 21 CFR 878.4683
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 MDR events
8 adverse event reports on file
- NEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUSAug 12, 2023MalfunctionKalyptoMW5137472
- SNAPJun 14, 2021MalfunctionKci Usa, Inc.11991159
- SNAP 125MMHG THERAPY CARTRIDGEAug 9, 2019InjuryKinetic Concepts, Inc.3009897021-2019-00112
- SNAP¿ 125MMHG THERAPY CARTRIDGEJul 17, 2019InjuryKinetic Concepts, Inc.3009897021-2019-00081
- SNAP¿ THERAPY SYSTEMJun 1, 2018InjuryKinetic Concepts, Inc.3009897021-2018-00053
- SNAP¿ THERAPY SYSTEMMar 9, 2018InjuryKinetic Concepts, Inc.3009897021-2018-00017
- SNAP WOUND CARE SYSTEM: SNAP FOAM DRESSING KITAug 25, 2014InjurySpiracur Inc.3008087410-2014-00001
- WOUND VACJan 6, 2010InjuryKci, Inc.MW5014261
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
24 firms currently registered for this product code
Kci Usa, Inc.
San Antonio, TX, US
Sterigenics U.s. Llc
Hayward, CA, US
Benq Materials Corporation
Gueishan Taoyuan, TW
Synergy Health Westport Ltd
Westport Mayo, IE
Stryker Instruments
Portage, MI, US
Isomedix Operations, Inc.
Libertyville, IL, US
Cordica Medical, Inc. (formally Team Technologies, Inc.)
Haverhill, MA, US
Isomedix Operations Inc.
CHESTER, NY, US
Systagenix Wound Management Manufacturing Limited
North Yorkshire, GB
Kci Usa, Inc.
SAN ANTONIO, TX, US
Kci Manufacturing
Athlone - Co. Westmeath, IE
510(k) clearances
17 clearances for this product code
- Guard Medical, Inc.May 15, 2025
K251156 · NPseal
- Guard Medical, Inc.Apr 8, 2025
K250708 · NPseal
- Guard Medical, Inc.Aug 15, 2024
K241522 · NPseal (20 and 25)
- Guard Medical, Inc.Feb 29, 2024
K240244 · NPseal (Small, Medium, Large)
- Guard Medical, Inc.Feb 10, 2022
K212971 · NPseal
- Guard Medical, Inc.May 14, 2021
K211130 · NPseal
- Guard Medical, Inc.May 26, 2020
K200305 · NPseal
- Benq Materials CorporationMay 4, 2020
K193185 · Anscare SIMO Negative Pressure Wound Therapy (NPWT) System