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FDA 510(k)

ED-3410, VIDEO DUODENOSCOPE

K-Number: K963056 · 1996-10-10

ApplicantPentax Precision Instrument Corp.
Decision Date1996-10-10
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ED-3410, VIDEO DUODENOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Precision Instrument Corp.. It received FDA 510(k) clearance on 1996-10-10 under 510(k) number K963056. 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 ED-3410, VIDEO DUODENOSCOPE?

ED-3410, VIDEO DUODENOSCOPE is a medical device that received FDA 510(k) clearance on 1996-10-10. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K963056.

When did ED-3410, VIDEO DUODENOSCOPE receive FDA 510(k) clearance?

ED-3410, VIDEO DUODENOSCOPE received FDA 510(k) clearance on 1996-10-10, under 510(k) number K963056.

Who is the listed applicant for ED-3410, VIDEO DUODENOSCOPE?

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

What is the FDA product code for ED-3410, VIDEO DUODENOSCOPE?

The FDA product code for ED-3410, VIDEO DUODENOSCOPE is FDT.

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Other records listing Pentax Precision Instrument Corp. 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.

K041395EG-3630URK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK041397EG-3830UTK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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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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