Ucb

FDA 510(k) K950689 · Cox Medical Ent., Inc.

Substantially Equivalent

510(k) numberK950689

Submission

Device name
Ucb
Applicant
Cox Medical Ent., Inc.
Ventura, CA, US
Received
February 14, 1995
Decision date
March 6, 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
K946293Mill-Rose Scope Cleaning BrushMNL · Traditional Mill-Rose Laboratory02/16/1995SE
K892218Endo-SpongeMNL · Traditional Endovations05/31/1989SE
K874239Cleaning BrushMNL · Traditional Endovations12/29/1987SE

More from Endovations

510(k)DeviceDecision
K946360Modular Biopsy ForcepFCL · Traditional 03/06/1995SE
K941464Basics Endoscopy SystemOCZ · Traditional 08/05/1994SE
K940911Basics Endoscopy SystemKGE · Traditional 05/16/1994SE
K932790Thermal OptionKGE · Traditional 01/28/1994SE
K935250Accu-PathFCL · Traditional 01/21/1994SE
K924655Cox Disposable Endoscope Cleaning BRUSH(CB-X2)FEB · Traditional 12/15/1992SE
K923671Cox Disposable Polypectomy SnaresFDI · Traditional 10/13/1992SE
K923672Cox Disposable Endoscope Cleaning BrushFEB · Traditional 09/23/1992SE
K923489Cox Disposable Retrieval DevicesOCZ · Traditional 09/23/1992SE
K914466Cox Disposable Cytology BrushesFDX · Traditional 10/25/1991SE

Questions and answers

When was Ucb cleared by the FDA?

Ucb (K950689) received a 510(k) decision of Substantially Equivalent on March 6, 1995, 20 days after the submission was received.

What is the product code of K950689?

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