Designs for Vision Fiberoptic Light

FDA 510(k) K032283 · Designs For Vision, Inc.

Substantially Equivalent

510(k) numberK032283

Submission

Device name
Designs for Vision Fiberoptic Light
Applicant
Designs For Vision, Inc.
North Attleboro, MA, US
Received
July 24, 2003
Decision date
August 20, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

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
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
K843900Focuscope Universal SystemGDB · Traditional Medical Diagnostics, Ca.12/06/1984SE
K810007Pentax Upper G.I. Fiberscope, #FG-34GDB · Traditional Pentax Precision Instrument Corp.01/15/1981SE

More from Pentax Precision Instrument Corp.

510(k)DeviceDecision
K051786Melide Fiberoptic LightFST · Special 08/15/2005SE
K043530Dvi Curing LightEBZ · Traditional 01/25/2005SE
K013880Daylite Xenon Light SourcesGCT · Traditional 12/07/2001SE
K801058Illuminated SpeculumFXF · Traditional 05/28/1980SE

Questions and answers

When was Designs for Vision Fiberoptic Light cleared by the FDA?

Designs for Vision Fiberoptic Light (K032283) received a 510(k) decision of Substantially Equivalent on August 20, 2003, 27 days after the submission was received.

What is the product code of K032283?

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