Mill-Rose Scope Cleaning Brush

FDA 510(k) K946293 · Mill-Rose Laboratory

Substantially Equivalent

510(k) numberK946293

Submission

Device name
Mill-Rose Scope Cleaning Brush
Applicant
Mill-Rose Laboratory
Mentor, OH, US
Received
December 27, 1994
Decision date
February 16, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
K892218Endo-SpongeMNL · Traditional Endovations05/31/1989SE
K874239Cleaning BrushMNL · Traditional Endovations12/29/1987SE

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K971275Mill-Rose Disposable Polypectomy SnareFDI · Traditional 05/23/1997SE
K962736Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional 07/29/1996SE
K960880Mill-Rose Blind Microbiology BrushEOQ · Traditional 04/29/1996SE
K954519Wang Transendoscopic Aspiration NeedleFBK · Traditional 12/22/1995SE
K951600Mill-Rose Rotatable Polypectomy SnareFDI · Traditional 12/18/1995SE
K954745Mill-Rose Rigid Scope Cleaning BrushesFEB · Traditional 11/27/1995SE
K951051Rite-Bite Biopsy ForcepsEOQ · Traditional 03/24/1995SE
K951048Rite-Bite Biopsy ForcepsFCL · Traditional 03/15/1995SE

Questions and answers

When was Mill-Rose Scope Cleaning Brush cleared by the FDA?

Mill-Rose Scope Cleaning Brush (K946293) received a 510(k) decision of Substantially Equivalent on February 16, 1995, 51 days after the submission was received.

What is the product code of K946293?

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