Focuscope Universal System

FDA 510(k) K843900 · Medical Diagnostics, Ca.

Substantially Equivalent

510(k) numberK843900

Submission

Device name
Focuscope Universal System
Applicant
Medical Diagnostics, Ca.
Valrico, FL, US
Received
October 3, 1984
Decision date
December 6, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GDB – Endoscope, Fiber Optic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code GDB

510(k)DeviceApplicantDecision
K032283Designs for Vision Fiberoptic LightGDB · Special Designs For Vision, Inc.08/20/2003SE
K961536FlexscopeGDB · Traditional Matrix Medica, Inc.09/18/1996SE
K935818EndoscopeGDB · Traditional Cuda Products Co.07/13/1994SE
K882061Olympus GF-UM3/EU-M3GDB · Traditional Olympus Corp.11/15/1988SE
K855151Fritch Ophthalmic EndoscopeGDB · Traditional Regtec02/19/1986SE
K810007Pentax Upper G.I. Fiberscope, #FG-34GDB · Traditional Pentax Precision Instrument Corp.01/15/1981SE

More from Pentax Precision Instrument Corp.

510(k)DeviceDecision
K853140Mdi Quik Test Narcotics Drug ScreenDNK · Traditional 03/03/1986SE
K843343Medica Iif-Anti-Thyroid Antibody TestJZO · Traditional 10/22/1984SE
K831100Medica Iif-Multiple Antibody Test KitDBM · Traditional 05/04/1983SE

Questions and answers

When was Focuscope Universal System cleared by the FDA?

Focuscope Universal System (K843900) received a 510(k) decision of Substantially Equivalent on December 6, 1984, 64 days after the submission was received.

What is the product code of K843900?

The FDA product code is GDB – Endoscope, Fiber Optic, a Class II (moderate risk) device regulated under 21 CFR 876.1500.