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FDA 510(k)

SAPIMED DISPOSABLE SIGMOIDOSCOPE

K-Number: K070915 · 2007-07-06

ApplicantSapimed S.P.A.
Decision Date2007-07-06
Product CodeKDM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SAPIMED DISPOSABLE SIGMOIDOSCOPE 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 2007-07-06 under 510(k) number K070915. The device is classified under product code KDM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPIMED DISPOSABLE SIGMOIDOSCOPE?

SAPIMED DISPOSABLE SIGMOIDOSCOPE is a medical device that received FDA 510(k) clearance on 2007-07-06. The listed applicant is Sapimed S.P.A.. The 510(k) number is K070915.

When did SAPIMED DISPOSABLE SIGMOIDOSCOPE receive FDA 510(k) clearance?

SAPIMED DISPOSABLE SIGMOIDOSCOPE received FDA 510(k) clearance on 2007-07-06, under 510(k) number K070915.

Who is the listed applicant for SAPIMED DISPOSABLE SIGMOIDOSCOPE?

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 SAPIMED DISPOSABLE SIGMOIDOSCOPE?

The FDA product code for SAPIMED DISPOSABLE SIGMOIDOSCOPE is KDM.

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.5660K070913SELF-LIGHT DISPOSABLE ANOSCOPE

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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