Forceps, Biopsy, Electric, Reprocessed
Gastroenterology, Urology · 21 CFR 876.4300
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).
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
5 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Sterilmed, Inc.Jul 20, 2005
K050136 · REPROCESSED HOT BIOPSY FORCEPS
- Clearmedical, Inc.Nov 20, 2003
K033593 · REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
- Surgical Instruments Service and Savings, Inc.Dec 19, 2002
K024011 · SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
- Vanguard Medical Concepts, Inc.Sep 27, 2001
K011800 · VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS