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FDA 510(k)

INVENDO C25 COLONOSCOPY SYSTEM

K-Number: K121582 · 2012-12-20

ApplicantInvendo Medical Gbmh
Decision Date2012-12-20
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INVENDO C25 COLONOSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Invendo Medical Gbmh. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K121582. 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 INVENDO C25 COLONOSCOPY SYSTEM?

INVENDO C25 COLONOSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Invendo Medical Gbmh. The 510(k) number is K121582.

When did INVENDO C25 COLONOSCOPY SYSTEM receive FDA 510(k) clearance?

INVENDO C25 COLONOSCOPY SYSTEM received FDA 510(k) clearance on 2012-12-20, under 510(k) number K121582.

Who is the listed applicant for INVENDO C25 COLONOSCOPY SYSTEM?

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

What is the FDA product code for INVENDO C25 COLONOSCOPY SYSTEM?

The FDA product code for INVENDO C25 COLONOSCOPY SYSTEM 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.

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Other records listing Invendo Medical Gbmh 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.

K100624INVENDO C20 COLONOSCOPY 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.

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

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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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