510(k) K050136

Device: REPROCESSED HOT BIOPSY FORCEPS
Applicant: STERILMED, INC.
510(k) number: K050136
Product code: NLU
Decision: Substantially Equivalent (SESE)
Decision date: 2005-07-20
Date received: 2005-01-21
Regulation: 876.4300
Classification name: Forceps, Biopsy, Electric, Reprocessed
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: BRUCE R LESTER
Address: 11400 73rd Ave. N Maple Grove MN US 55369 55369

FDA Registration Numbers#

3032391
1061124
2011171
1018470
3011024991

Source Documents#

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

Other 510(k) Records For Product Code NLU #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
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

Legacy Summary#

summary

FDA Review#

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