Forceps, Biopsy, Electric, Reprocessed
FDA product code NLU · Class II (moderate risk) · 21 CFR 876.4300 · Gastroenterology, Urology
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).
4510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050136 | Reprocessed Hot Biopsy ForcepsNLU · Traditional | Sterilmed, Inc. | 07/20/2005SE |
| K033593 | Reprocessed Single Use Devices Biopsy ForcepsNLU · Traditional | Clearmedical, Inc. | 11/20/2003SE |
| K024011 | Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical…NLU · Traditional | Surgical Instruments Service and Savings, Inc. | 12/19/2002SE |
| K011800 | Vanguard Reprocessed Electric Biopsy ForcepsNLU · Traditional | Vanguard Medical Concepts, Inc. | 09/27/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0549-2009 | Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550 Laparoscopic…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |