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FDA 510(k)

EG-3630UR, ULTRASUND VIDEO GASTROSCOPE

K-Number: K013640 · 2002-02-04

ApplicantPentax Precision Instrument Corp.
Decision Date2002-02-04
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EG-3630UR, ULTRASUND VIDEO GASTROSCOPE 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 2002-02-04 under 510(k) number K013640. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EG-3630UR, ULTRASUND VIDEO GASTROSCOPE?

EG-3630UR, ULTRASUND VIDEO GASTROSCOPE is a medical device that received FDA 510(k) clearance on 2002-02-04. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K013640.

When did EG-3630UR, ULTRASUND VIDEO GASTROSCOPE receive FDA 510(k) clearance?

EG-3630UR, ULTRASUND VIDEO GASTROSCOPE received FDA 510(k) clearance on 2002-02-04, under 510(k) number K013640.

Who is the listed applicant for EG-3630UR, ULTRASUND VIDEO GASTROSCOPE?

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 EG-3630UR, ULTRASUND VIDEO GASTROSCOPE?

The FDA product code for EG-3630UR, ULTRASUND VIDEO GASTROSCOPE is FDS.

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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.

K041397EG-3830UTK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK041395EG-3630URK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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Related Devices (Code: FDS)

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.

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/SK260856Disposable Distal Attachment D-201-13404Olympus Medical Systems CorporationK260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems CorporationK253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation

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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