Product code NLU

Device name: Forceps, Biopsy, Electric, Reprocessed
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.4300
Review panel: GU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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).
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K050136	REPROCESSED HOT BIOPSY FORCEPS	Sterilmed, Inc.	2005-07-20
K033593	REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS	Clearmedical, Inc.	2003-11-20
K024011	SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES	Surgical Instruments Service and Savings, Inc.	2002-12-19
K011800	VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS	Vanguard Medical Concepts, Inc.	2001-09-27

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10888551001663	NA	STERILMED, INC.	2016-09-22
10888551001717	NA	STERILMED, INC.	2016-09-22
10888551007962	NA	STERILMED, INC.	2016-09-22
10888551013482	NA	STERILMED, INC.	2016-09-22
10888551013499	NA	STERILMED, INC.	2016-09-22

Related 510(k) Records#