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FDA 510(k)

PENTEX UPPER G.I. SCOPE MODEL FG-28A

K-Number: K792215 · 1979-12-10

ApplicantPentax Precision Instrument Corp.
Decision Date1979-12-10
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTEX UPPER G.I. SCOPE MODEL FG-28A 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 1979-12-10 under 510(k) number K792215. The device is classified under product code GCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTEX UPPER G.I. SCOPE MODEL FG-28A?

PENTEX UPPER G.I. SCOPE MODEL FG-28A is a medical device that received FDA 510(k) clearance on 1979-12-10. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K792215.

When did PENTEX UPPER G.I. SCOPE MODEL FG-28A receive FDA 510(k) clearance?

PENTEX UPPER G.I. SCOPE MODEL FG-28A received FDA 510(k) clearance on 1979-12-10, under 510(k) number K792215.

Who is the listed applicant for PENTEX UPPER G.I. SCOPE MODEL FG-28A?

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 PENTEX UPPER G.I. SCOPE MODEL FG-28A?

The FDA product code for PENTEX UPPER G.I. SCOPE MODEL FG-28A is GCT.

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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: GCT)

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.

K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbHK082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed LinvatecK040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.K022490KSEA MEDI PACKKARL STORZ Endoscopy-America, Inc.K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp.

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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