Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CLEARPATH LOWER GI

K-Number: K113050 · 2012-05-16

ApplicantEasyglide , Ltd.
Decision Date2012-05-16
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLEARPATH LOWER GI is the device name listed in this FDA 510(k) record. The listed applicant is Easyglide , Ltd.. It received FDA 510(k) clearance on 2012-05-16 under 510(k) number K113050. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARPATH LOWER GI?

CLEARPATH LOWER GI is a medical device that received FDA 510(k) clearance on 2012-05-16. The listed applicant is Easyglide , Ltd.. The 510(k) number is K113050.

When did CLEARPATH LOWER GI receive FDA 510(k) clearance?

CLEARPATH LOWER GI received FDA 510(k) clearance on 2012-05-16, under 510(k) number K113050.

Who is the listed applicant for CLEARPATH LOWER GI?

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

What is the FDA product code for CLEARPATH LOWER GI?

The FDA product code for CLEARPATH LOWER GI is FDF.

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 Easyglide , Ltd. 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.

K113166CLEARPATH UPPER GIK101094CLEARJETK093779CLEARPATH UGIK091305CLEARPATH

Related Devices (Code: FDF)

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.

K260503Triton 1 SystemNeptune Medical, Inc.K261015Solo Scope Colonoscope SystemGi View, Ltd.K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.

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.

↑