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FDA 510(k)

FG-36UX FIBER ULTRASOUND GASTROSCOPE

K-Number: K041396 · 2004-06-09

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

Device Summary

FG-36UX FIBER ULTRASOUND 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 2004-06-09 under 510(k) number K041396. 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 FG-36UX FIBER ULTRASOUND GASTROSCOPE?

FG-36UX FIBER ULTRASOUND GASTROSCOPE 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 K041396.

When did FG-36UX FIBER ULTRASOUND GASTROSCOPE receive FDA 510(k) clearance?

FG-36UX FIBER ULTRASOUND GASTROSCOPE received FDA 510(k) clearance on 2004-06-09, under 510(k) number K041396.

Who is the listed applicant for FG-36UX FIBER ULTRASOUND 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 FG-36UX FIBER ULTRASOUND GASTROSCOPE?

The FDA product code for FG-36UX FIBER ULTRASOUND GASTROSCOPE is ITX.

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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-3630URK041397EG-3830UTK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPEK021276FG-36UX FIBER ULTRASOUND GASTROSCOPE

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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.

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