FHF — System, Evacuator, Fluid Class II

FDA Device Classification

FDA product code FHF covers "System, Evacuator, Fluid", a Class II medical device regulated under 21 CFR 876.4370. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FHF
Device Class
Class II
Regulation Number
876.4370
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K093479modern medical equipment mfgDISPOSABLE SUCTION AND IRRIGATION SYSTEMMay 19, 2010
K003443applied medicalSUCTION IRRIGATORFebruary 1, 2001
K771986minnesota back braceCATHETER, MEDIASTINAL&PERICARDIALOctober 28, 1977