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FDA 510(k)

PENTAX Medical Video Colonoscope EC34-i10T Series

K-Number: K180285 · 2018-10-26

ApplicantPentax Medical of America, Inc.
Decision Date2018-10-26
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Video Colonoscope EC34-i10T Series is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical of America, Inc.. It received FDA 510(k) clearance on 2018-10-26 under 510(k) number K180285. 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 PENTAX Medical Video Colonoscope EC34-i10T Series?

PENTAX Medical Video Colonoscope EC34-i10T Series is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Pentax Medical of America, Inc.. The 510(k) number is K180285.

When did PENTAX Medical Video Colonoscope EC34-i10T Series receive FDA 510(k) clearance?

PENTAX Medical Video Colonoscope EC34-i10T Series received FDA 510(k) clearance on 2018-10-26, under 510(k) number K180285.

Who is the listed applicant for PENTAX Medical Video Colonoscope EC34-i10T Series?

The FDA 510(k) record lists Pentax Medical of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical Video Colonoscope EC34-i10T Series?

The FDA product code for PENTAX Medical Video Colonoscope EC34-i10T Series is FDF.

Other records listing Pentax Medical of America, Inc. 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.

K180292PENTAX Video Upper G.I. Scope EG34-i10

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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