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FDA 510(k)

MODEL TX-8 PANENDOSCOPE

K-Number: K760822 · 1976-10-21

ApplicantAmerican Cystocope Makers, Inc.
Decision Date1976-10-21
Product CodeFAK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL TX-8 PANENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is American Cystocope Makers, Inc.. It received FDA 510(k) clearance on 1976-10-21 under 510(k) number K760822. The device is classified under product code FAK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL TX-8 PANENDOSCOPE?

MODEL TX-8 PANENDOSCOPE is a medical device that received FDA 510(k) clearance on 1976-10-21. The listed applicant is American Cystocope Makers, Inc.. The 510(k) number is K760822.

When did MODEL TX-8 PANENDOSCOPE receive FDA 510(k) clearance?

MODEL TX-8 PANENDOSCOPE received FDA 510(k) clearance on 1976-10-21, under 510(k) number K760822.

Who is the listed applicant for MODEL TX-8 PANENDOSCOPE?

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

What is the FDA product code for MODEL TX-8 PANENDOSCOPE?

The FDA product code for MODEL TX-8 PANENDOSCOPE is FAK.

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Other records listing American Cystocope Makers, Inc. as applicant

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Related Devices (Code: FAK)

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.

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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.

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