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FDA 510(k)

CLEARPATH UPPER GI

K-Number: K113166 · 2012-05-16

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

Device Summary

CLEARPATH UPPER 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 K113166. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARPATH UPPER GI?

CLEARPATH UPPER 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 K113166.

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

CLEARPATH UPPER GI received FDA 510(k) clearance on 2012-05-16, under 510(k) number K113166.

Who is the listed applicant for CLEARPATH UPPER 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 UPPER GI?

The FDA product code for CLEARPATH UPPER GI is FDS.

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.

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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.

K113050CLEARPATH LOWER GIK101094CLEARJETK093779CLEARPATH UGIK091305CLEARPATH

Related Devices (Code: FDS)

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.

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/SK260856Disposable Distal Attachment D-201-13404Olympus Medical Systems CorporationK260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems CorporationK253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation

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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