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FDA 510(k)

AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE

K-Number: K851374 · 1985-06-28

ApplicantAmerican Edwards Laboratories
Decision Date1985-06-28
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1985-06-28 under 510(k) number K851374. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE?

AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1985-06-28. The listed applicant is American Edwards Laboratories. The 510(k) number is K851374.

When did AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE receive FDA 510(k) clearance?

AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE received FDA 510(k) clearance on 1985-06-28, under 510(k) number K851374.

Who is the listed applicant for AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE?

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

What is the FDA product code for AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE?

The FDA product code for AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE is HRX.

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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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