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-3830UT

K-Number: K041397 · 2004-06-09

ApplicantPentax Precision Instrument Corp.
Decision Date2004-06-09
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EG-3830UT 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 2004-06-09 under 510(k) number K041397. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EG-3830UT?

EG-3830UT is a medical device that received FDA 510(k) clearance on 2004-06-09. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K041397.

When did EG-3830UT receive FDA 510(k) clearance?

EG-3830UT received FDA 510(k) clearance on 2004-06-09, under 510(k) number K041397.

Who is the listed applicant for EG-3830UT?

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-3830UT?

The FDA product code for EG-3830UT is ITX.

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 GASTROSCOPEK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPEK021276FG-36UX FIBER ULTRASOUND GASTROSCOPE

View all 67 devices →

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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.

↑