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FDA 510(k)

FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE

K-Number: K961974 · 1997-02-10

ApplicantPentax Precision Instrument Corp.
Decision Date1997-02-10
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE 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 1997-02-10 under 510(k) number K961974. 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, ULTRASOUND UPPER GI FIBERSCOPE?

FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K961974.

When did FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE receive FDA 510(k) clearance?

FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE received FDA 510(k) clearance on 1997-02-10, under 510(k) number K961974.

Who is the listed applicant for FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE?

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, ULTRASOUND UPPER GI FIBERSCOPE?

The FDA product code for FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE 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-3830UTK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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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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