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FDA 510(k)

E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM

K-Number: K131131 · 2013-06-21

ApplicantIntromedic Co., Ltd.
Decision Date2013-06-21
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intromedic Co., Ltd.. It received FDA 510(k) clearance on 2013-06-21 under 510(k) number K131131. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM?

E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-21. The listed applicant is Intromedic Co., Ltd.. The 510(k) number is K131131.

When did E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM receive FDA 510(k) clearance?

E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM received FDA 510(k) clearance on 2013-06-21, under 510(k) number K131131.

Who is the listed applicant for E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM?

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

What is the FDA product code for E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM?

The FDA product code for E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM is EOX.

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Other records listing Intromedic Co., Ltd. as applicant

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K252617MiroCam® Capsule Endoscope SystemK180732MiroCam Capsule Endoscope SystemK170438MiroCam Capsule Endoscope SystemK123428MIROCAM CAPSULE ENDOSCOPE SYSTEMK120702E.G. SCAN II ESPHAGOSCOPE SYSTEMK111450MIROCAM CAPSULE ENDOSCOPE SYSTEM

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Related Devices (Code: EOX)

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.

K233142EndoSign® Cell collection device (ES-CYT-102)Cyted LimitedK230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLCK210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.

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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