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Forceps, Biopsy, Electric, Reprocessed

FDA product code NLU · 4 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.4300
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2001-09-27 – 2005-07-20

The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied. This device is indicated for reuse/reprocessing. 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).

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