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FDA 510(k)

E.G. SCAN II ESPHAGOSCOPE SYSTEM

K-Number: K120702 · 2012-06-20

ApplicantIntromedic Co., Ltd.
Decision Date2012-06-20
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

E.G. SCAN II ESPHAGOSCOPE 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 2012-06-20 under 510(k) number K120702. 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 II ESPHAGOSCOPE SYSTEM?

E.G. SCAN II ESPHAGOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-20. The listed applicant is Intromedic Co., Ltd.. The 510(k) number is K120702.

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

E.G. SCAN II ESPHAGOSCOPE SYSTEM received FDA 510(k) clearance on 2012-06-20, under 510(k) number K120702.

Who is the listed applicant for E.G. SCAN II ESPHAGOSCOPE 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 II ESPHAGOSCOPE SYSTEM?

The FDA product code for E.G. SCAN II ESPHAGOSCOPE 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 SystemK131131E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEMK123428MIROCAM CAPSULE ENDOSCOPE 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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