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FDA 510(k)

invendoscopy E200 System

K-Number: K161355 · 2016-08-25

ApplicantInvendo Medical GmbH
Decision Date2016-08-25
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

invendoscopy E200 System is the device name listed in this FDA 510(k) record. The listed applicant is Invendo Medical GmbH. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161355. 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 invendoscopy E200 System?

invendoscopy E200 System is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Invendo Medical GmbH. The 510(k) number is K161355.

When did invendoscopy E200 System receive FDA 510(k) clearance?

invendoscopy E200 System received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161355.

Who is the listed applicant for invendoscopy E200 System?

The FDA 510(k) record lists Invendo Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for invendoscopy E200 System?

The FDA product code for invendoscopy E200 System is FDF.

Other records listing Invendo Medical GmbH 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.

K173085invendoscopy E210 System

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.

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.K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFujifilm CorporationK250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)Olympus Medical Systems Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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