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FDA 510(k)

GF-UE160-AL5 ULTRASOUND ENDOSCOPE

K-Number: K051541 · 2005-07-01

ApplicantOlympus America, Inc.
Decision Date2005-07-01
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GF-UE160-AL5 ULTRASOUND ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2005-07-01 under 510(k) number K051541. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GF-UE160-AL5 ULTRASOUND ENDOSCOPE?

GF-UE160-AL5 ULTRASOUND ENDOSCOPE is a medical device that received FDA 510(k) clearance on 2005-07-01. The listed applicant is Olympus America, Inc.. The 510(k) number is K051541.

When did GF-UE160-AL5 ULTRASOUND ENDOSCOPE receive FDA 510(k) clearance?

GF-UE160-AL5 ULTRASOUND ENDOSCOPE received FDA 510(k) clearance on 2005-07-01, under 510(k) number K051541.

Who is the listed applicant for GF-UE160-AL5 ULTRASOUND ENDOSCOPE?

The FDA 510(k) record lists Olympus America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GF-UE160-AL5 ULTRASOUND ENDOSCOPE?

The FDA product code for GF-UE160-AL5 ULTRASOUND ENDOSCOPE is FDF.

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Other records listing Olympus America, Inc. as applicant

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Related Devices (Code: FDF)

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.

K260503Triton 1 SystemNeptune Medical, Inc.K261015Solo Scope Colonoscope SystemGi View, Ltd.K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.

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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