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NON — Forceps, Biopsy, Non-Electric, Reprocessed Class I

FDA Device Classification

Classification Details

Product Code
NON
Device Class
Class I
Regulation Number
876.1075
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

same as procode FCL except this product is for the reprocessed device. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K042648sterilmedREPROCESSED COLD BIOPSY FORCEPSJuly 20, 2005
K042659medisissMEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPSFebruary 14, 2005
K042594vanguard medical conceptsVANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPSJanuary 25, 2005