NLU — Forceps, Biopsy, Electric, Reprocessed Class II
Classification Details
- Product Code
- NLU
- Device Class
- Class II
- Regulation Number
- 876.4300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
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 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050136 | sterilmed | REPROCESSED HOT BIOPSY FORCEPS | July 20, 2005 |
| K033593 | clearmedical | REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS | November 20, 2003 |
| K024011 | surgical instruments service and savings | SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICA | December 19, 2002 |
| K011800 | vanguard medical concepts | VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS | September 27, 2001 |