Forceps, Biopsy, Electric, Reprocessed
The Reprocessed Electric Biopsy Forceps is a reprocessed endoscopic device used to obtain tissue samples for histopathological examination, allow coagulation to prevent bleeding, and destroy lesion residuum using electric current during endoscopic procedures; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLU and regulation 21 CFR 876.4300 in the Gastroenterology and Urology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- NLU
- Device Class
- FDA class 2
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050136 | REPROCESSED HOT BIOPSY FORCEPS | Jul 20, 2005 | Substantially Equivalent | Sterilmed, Inc. |
| K033593 | REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS | Nov 20, 2003 | Substantially Equivalent | Clearmedical, Inc. |
| K024011 | SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES | Dec 19, 2002 | Substantially Equivalent | Surgical Instruments Service and Savings, Inc. |
| K011800 | VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS | Sep 27, 2001 | Substantially Equivalent | Vanguard Medical Concepts, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.