Cleaning Brush

FDA 510(k) K874239 · Endovations

Substantially Equivalent

510(k) numberK874239

Submission

Device name
Cleaning Brush
Applicant
Endovations
Camp Hill, PA, US
Received
October 16, 1987
Decision date
December 29, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MNL – Accessories, Cleaning Brushes, For Endoscope
Device class
Class I (low risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code MNL

510(k)DeviceApplicantDecision
K950689UcbMNL · Traditional Cox Medical Ent., Inc.03/06/1995SE
K946293Mill-Rose Scope Cleaning BrushMNL · Traditional Mill-Rose Laboratory02/16/1995SE
K892218Endo-SpongeMNL · Traditional Endovations05/31/1989SE

More from Endovations

510(k)DeviceDecision
K955413Endovations Triple Lumen Balloon Dilatation CatheterFGE · Traditional 02/08/1996SE
K942110Inject-SnareFDI · Traditional 10/13/1994SE
K944049Oxygen MouthguardMNK · Traditional 10/11/1994SE
K934315Endovations(R) .035 Pre-Cut PapillatomeKNS · Traditional 02/28/1994SE
K9138412 Lumen Endos Retro Cholangiopancrea Injec CathFGE · Traditional 10/08/1991SE
K9138705MM MicroscissorsGCJ · Traditional 09/16/1991SE
K911155Oval Cup Biopsy ForcepFCF · Traditional 08/07/1991SE
K892218Endo-SpongeMNL · Traditional 05/31/1989SE
K883093Transendoscopic Aspiration NeedleFBK · Traditional 12/08/1988SE
K873360Enteron Percutan. Endoscopic Gastrostomy Tray-PegKNT · Traditional 03/30/1988SE

Questions and answers

When was Cleaning Brush cleared by the FDA?

Cleaning Brush (K874239) received a 510(k) decision of Substantially Equivalent on December 29, 1987, 74 days after the submission was received.

What is the product code of K874239?

The FDA product code is MNL – Accessories, Cleaning Brushes, For Endoscope, a Class I (low risk) device regulated under 21 CFR 876.1500.