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FDA 510(k)

PENTAX ED-3490TK, VIDEO DUODENOSCOPE

K-Number: K092710 · 2009-12-02

ApplicantPentax Medical Company
Decision Date2009-12-02
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX ED-3490TK, VIDEO DUODENOSCOPE 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 2009-12-02 under 510(k) number K092710. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX ED-3490TK, VIDEO DUODENOSCOPE?

PENTAX ED-3490TK, VIDEO DUODENOSCOPE is a medical device that received FDA 510(k) clearance on 2009-12-02. The listed applicant is Pentax Medical Company. The 510(k) number is K092710.

When did PENTAX ED-3490TK, VIDEO DUODENOSCOPE receive FDA 510(k) clearance?

PENTAX ED-3490TK, VIDEO DUODENOSCOPE received FDA 510(k) clearance on 2009-12-02, under 510(k) number K092710.

Who is the listed applicant for PENTAX ED-3490TK, VIDEO DUODENOSCOPE?

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 PENTAX ED-3490TK, VIDEO DUODENOSCOPE?

The FDA product code for PENTAX ED-3490TK, VIDEO DUODENOSCOPE is FDT.

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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.

K093037PENTEX EC-3890LIK090197EG-3870UTKK090196EG-3670URKK081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UKK061068EG-3670URKK042741EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE

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Related Devices (Code: FDT)

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.

K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm CorporationK253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S

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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