GBT — Catheter, Rectal Class II

FDA Device Classification

Classification Details

Product Code
GBT
Device Class
Class II
Regulation Number
876.5980
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K941391innovatec medicalINFLATABLE RETENTION CUFF SPECULUMOctober 20, 1994
K924549tri-med specialtiesTRI-MED QUICK-STEP(TM) RECTAL TUBEFebruary 10, 1994
K890466tonometricsSIGMOID TONOMITORApril 21, 1989