Pro-Scope

FDA 510(k) K822085 · Exitec, Inc.

Substantially Equivalent

510(k) numberK822085

Submission

Device name
Pro-Scope
Applicant
Exitec, Inc.
Mchenry, IL, US
Received
July 13, 1982
Decision date
May 9, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FER – Anoscope And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

To examine and perform procedures within the anus and rectum.

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K133687THD N-Ano AnoscopeFER · Special Thd Spa12/11/2013SE
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K110792Gelpoint PathFER · Traditional Applied Medical Resources Corp.05/23/2011SE

More from Applied Medical Resources Corp.

510(k)DeviceDecision
K822087Dia ScopeKNT · Traditional 11/17/1982SE
K822086Dia-SpecHIB · Traditional 11/08/1982SE
K822084Pro-SpecHIB · Traditional 08/19/1982SE

Questions and answers

When was Pro-Scope cleared by the FDA?

Pro-Scope (K822085) received a 510(k) decision of Substantially Equivalent on May 9, 1983, 300 days after the submission was received.

What is the product code of K822085?

The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.