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FDA 510(k)

PRO-SCOPE

K-Number: K822085 · 1983-05-09

ApplicantExitec, Inc.
Decision Date1983-05-09
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRO-SCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Exitec, Inc.. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K822085. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-SCOPE?

PRO-SCOPE is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Exitec, Inc.. The 510(k) number is K822085.

When did PRO-SCOPE receive FDA 510(k) clearance?

PRO-SCOPE received FDA 510(k) clearance on 1983-05-09, under 510(k) number K822085.

Who is the listed applicant for PRO-SCOPE?

The FDA 510(k) record lists Exitec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-SCOPE?

The FDA product code for PRO-SCOPE is FER.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Exitec, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K822087DIA SCOPEK822086DIA-SPECK822084PRO-SPEC

Related Devices (Code: FER)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250645SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)Haemoband Surgical, Ltd.K242668Gastro Concepts Air AssistGastro Concepts, LLCK230439WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd.K200021Applied Medical AnoscopeApplied Medical ResourcesK171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.K133687THD N-ANO ANOSCOPEThd Spa

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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