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FDA 510(k)

PENTEX EC-3890LI

K-Number: K093037 · 2009-12-28

ApplicantPentax Medical Company
Decision Date2009-12-28
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTEX EC-3890LI is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical Company. It received FDA 510(k) clearance on 2009-12-28 under 510(k) number K093037. 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 PENTEX EC-3890LI?

PENTEX EC-3890LI is a medical device that received FDA 510(k) clearance on 2009-12-28. The listed applicant is Pentax Medical Company. The 510(k) number is K093037.

When did PENTEX EC-3890LI receive FDA 510(k) clearance?

PENTEX EC-3890LI received FDA 510(k) clearance on 2009-12-28, under 510(k) number K093037.

Who is the listed applicant for PENTEX EC-3890LI?

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

What is the FDA product code for PENTEX EC-3890LI?

The FDA product code for PENTEX EC-3890LI is FDF.

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Other records listing Pentax Medical Company 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.

K092710PENTAX ED-3490TK, VIDEO DUODENOSCOPEK090197EG-3870UTKK090196EG-3670URKK081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UKK061068EG-3670URKK042741EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE

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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

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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