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FDA 510(k)

SELF-LIGHT DISPOSABLE ANOSCOPE

K-Number: K070913 · 2007-08-10

ApplicantSapimed S.P.A.
Decision Date2007-08-10
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SELF-LIGHT DISPOSABLE ANOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Sapimed S.P.A.. It received FDA 510(k) clearance on 2007-08-10 under 510(k) number K070913. 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 SELF-LIGHT DISPOSABLE ANOSCOPE?

SELF-LIGHT DISPOSABLE ANOSCOPE is a medical device that received FDA 510(k) clearance on 2007-08-10. The listed applicant is Sapimed S.P.A.. The 510(k) number is K070913.

When did SELF-LIGHT DISPOSABLE ANOSCOPE receive FDA 510(k) clearance?

SELF-LIGHT DISPOSABLE ANOSCOPE received FDA 510(k) clearance on 2007-08-10, under 510(k) number K070913.

Who is the listed applicant for SELF-LIGHT DISPOSABLE ANOSCOPE?

The FDA 510(k) record lists Sapimed S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELF-LIGHT DISPOSABLE ANOSCOPE?

The FDA product code for SELF-LIGHT DISPOSABLE ANOSCOPE 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 Sapimed S.P.A. 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.

K070881LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660K070915SAPIMED DISPOSABLE SIGMOIDOSCOPE

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

View on FDA Database →

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

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