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FDA 510(k)

TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.

K-Number: K864960 · 1987-02-10

ApplicantCooper Lasersonics, Inc.
Decision Date1987-02-10
Product CodeGCQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1987-02-10 under 510(k) number K864960. The device is classified under product code GCQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.?

TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. is a medical device that received FDA 510(k) clearance on 1987-02-10. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K864960.

When did TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. receive FDA 510(k) clearance?

TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. received FDA 510(k) clearance on 1987-02-10, under 510(k) number K864960.

Who is the listed applicant for TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.?

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

What is the FDA product code for TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.?

The FDA product code for TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. is GCQ.

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Other records listing Cooper Lasersonics, Inc. as applicant

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Related Devices (Code: GCQ)

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.

K920979CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)Codman & Shurtleff, Inc.K900894MEDILASE SERIES 2100 ENDOSCOPEMedical Laser, Inc.K871978CODMAN FLEXIBLE ENDOSCOPECodman & Shurtleff, Inc.K860771VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPEVan-Tec, 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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