Aspiration Tray
General, Plastic Surgery · 21 CFR 878.4800
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Recent MDR events
8 adverse event reports on file
- CUSTOM HEALTHCARE SYSTEMS, INCMay 29, 2025MalfunctionManus Medical, Llc22104885
- ASPIRATION TRAYJan 6, 2025MalfunctionManus Medical, Llc21085892
- SKATER¿ SAFETY CENTESIS CATHETERJan 3, 2025MalfunctionArgon Medical Devices, Inc.21066524
- ASPIRATION TRAYNov 14, 2024MalfunctionManus Medical, Llc20682929
- ASPIRATION TRAYMar 20, 2024OtherCustom Healthcare Systems, Inc.18941027
- CUSTOM HEALTHCARE SYSTEMSNov 28, 2023MalfunctionCustom Healthcare Systems, Inc.18217209
- CUSTOM HEALTHCARE SYSTEMS, INCNov 9, 2023MalfunctionCustom Healthcare System, Inc18102937
- CUSTOM HEALTHCARE SYSTEMS, INCOct 18, 2021MalfunctionCustom Healthcare Systems, Inc.12646903
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
20 firms currently registered for this product code
Carefusion 2200, Inc.
Vernon Hills, IL, US
Midwest Sterilization Corp.
JACKSON, MO, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Industries, Inc.
POWELL, TN, US
Isomedix Operations Inc
El Paso, TX, US
Trinity Sterile, Inc.
SALISBURY, MD, US
Argon Medical Devices Inc.
ATHENS, TX, US
Cardinal Health 200, Llc
El Paso, TX, US
Austin Medical, Inc.
Waynesville, NC, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Instrumed Gmbh Dba Avalign German Specialty Instruments
TUTTLINGEN Baden-Wurttemberg, DE
Cardinal Health 200, Llc
Waukegan, IL, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Midwest Sterilization Corp.
LAREDO, TX, US
Sterilization Services Of Virginia
RICHMOND, VA, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Sterigenics U.s., Llc
Charlotte, NC, US
Isomedix Operations Inc
EL PASO, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.