Eos Brand Disposable Proctoscope

FDA 510(k) K954614 · North Eos Industries, Inc.

Substantially Equivalent

510(k) numberK954614

Submission

Device name
Eos Brand Disposable Proctoscope
Applicant
North Eos Industries, Inc.
Taichung Hsien 423, TW
Received
October 5, 1995
Decision date
April 10, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GCP – Endoscope, Ac-Powered And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Other 510(k)s with product code GCP

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K896505Porges Universal HandlesGCP · Traditional Porges Corp.01/30/1990SE
K896008Model 6500 Mercury Arc Light SourceGCP · Traditional Medical Dynamics, Inc.12/27/1989SE
K862424Steerable Catheter SystemGCP · Traditional Endovations09/22/1986SE
K860103Mod. Endoport Single-Use Trocar and SleeveGCP · Traditional Endotherapeutics02/12/1986SE
K843683Modular Fiberscope SystemGCP · Traditional Reichert Scientific Instruments01/18/1985SE
K833859Tamponade Balloon CuffGCP · Traditional American Endoscopy, Inc.01/03/1984SE
K821999Endoscopic Sclerotherapy BalloonGCP · Traditional Retech08/27/1982SE
K801247CCD Endoscope and AttachmentsGCP · Traditional Welch Allyn, Inc.07/28/1980SE
K790071Endoscope and AccessoriesGCP · Traditional Olympus Corp.04/02/1979SE
K771920Fiber Optics ProctoscopeGCP · Traditional Propper Mfg. Co., Inc.10/20/1977SE

More from Propper Mfg. Co., Inc.

510(k)DeviceDecision
K963685Eos Brand Disposable Cyto/Cervical SamplerHHT · Traditional 10/11/1996SE
K963377Eos Brand Disposable Vaginal Speculum-EosspecHIB · Traditional 10/04/1996SE

Questions and answers

When was Eos Brand Disposable Proctoscope cleared by the FDA?

Eos Brand Disposable Proctoscope (K954614) received a 510(k) decision of Substantially Equivalent on April 10, 1996, 188 days after the submission was received.

What is the product code of K954614?

The FDA product code is GCP – Endoscope, Ac-Powered And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.