NLU
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Forceps, Biopsy, Electric, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Medical specialty
- Gastroenterology, Urology
- FDA 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).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| REPROCESSED HOT BIOPSY FORCEPS (K050136) | Sterilmed, Inc. | 2005-07-20 |
| REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (K033593) | Clearmedical, Inc. | 2003-11-20 |
| SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES (K024011) | Surgical Instruments Service and Savings, Inc. | 2002-12-19 |
| VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS (K011800) | Vanguard Medical Concepts, Inc. | 2001-09-27 |
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