FDA 510(k)

COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER

K-Number: K790338 · 1979-04-04

Decision Date1979-04-04

Product CodeFDF

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER is the device name listed in this FDA 510(k) record. The listed applicant is American Optical Corp.. It received FDA 510(k) clearance on 1979-04-04 under 510(k) number K790338. 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 COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER?

COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER is a medical device that received FDA 510(k) clearance on 1979-04-04. The listed applicant is American Optical Corp.. The 510(k) number is K790338.

When did COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER receive FDA 510(k) clearance?

COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER received FDA 510(k) clearance on 1979-04-04, under 510(k) number K790338.

Who is the listed applicant for COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER?

The FDA 510(k) record lists American Optical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER?

The FDA product code for COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER is FDF.

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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.