Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EG-3670URK

K-Number: K061068 · 2006-05-03

ApplicantPentax Medical Company
Decision Date2006-05-03
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EG-3670URK 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 2006-05-03 under 510(k) number K061068. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EG-3670URK?

EG-3670URK is a medical device that received FDA 510(k) clearance on 2006-05-03. The listed applicant is Pentax Medical Company. The 510(k) number is K061068.

When did EG-3670URK receive FDA 510(k) clearance?

EG-3670URK received FDA 510(k) clearance on 2006-05-03, under 510(k) number K061068.

Who is the listed applicant for EG-3670URK?

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 EG-3670URK?

The FDA product code for EG-3670URK is ODG.

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-3890LIK092710PENTAX ED-3490TK, VIDEO DUODENOSCOPEK090196EG-3670URKK090197EG-3870UTKK081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UKK042740ISC-1000 PENTAX CONFOCAL LASER SYSTEM

View all 8 devices →

Related Devices (Code: ODG)

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.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK260428RIVOS™ EUS Access Device (M00553900)Boston Scientific CorporationK251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK251542InstaFANOnepass Medical , Ltd.K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, Inc.

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.

↑