Product code NLU— 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).”

FDA has cleared 4 devices under product code NLU between 2001 and 2005, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20051 clearance
• 20031 clearance
• 20021 clearance
• 20011 clearance

• Vanguard Medical Concepts, Inc.1 clearance
• Surgical Instruments Service and Savings, Inc.1 clearance
• Sterilmed, Inc.1 clearance
• Clearmedical, Inc.1 clearance

• K050136 — REPROCESSED HOT BIOPSY FORCEPSSterilmed, Inc.·2005-07-20
• K033593 — REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPSClearmedical, Inc.·2003-11-20
• K024011 — SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIESSurgical Instruments Service and Savings, Inc.·2002-12-19
• K011800 — VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPSVanguard Medical Concepts, Inc.·2001-09-27