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FDA 510(k)

SHEPPERD DILATATION TUBE SET (GS-501-20-H)

K-Number: K900611 · 1990-10-22

ApplicantDowns Surgical , Ltd.
Decision Date1990-10-22
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHEPPERD DILATATION TUBE SET (GS-501-20-H) is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K900611. 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 SHEPPERD DILATATION TUBE SET (GS-501-20-H)?

SHEPPERD DILATATION TUBE SET (GS-501-20-H) is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K900611.

When did SHEPPERD DILATATION TUBE SET (GS-501-20-H) receive FDA 510(k) clearance?

SHEPPERD DILATATION TUBE SET (GS-501-20-H) received FDA 510(k) clearance on 1990-10-22, under 510(k) number K900611.

Who is the listed applicant for SHEPPERD DILATATION TUBE SET (GS-501-20-H)?

The FDA 510(k) record lists Downs Surgical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHEPPERD DILATATION TUBE SET (GS-501-20-H)?

The FDA product code for SHEPPERD DILATATION TUBE SET (GS-501-20-H) is HRX.

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Other records listing Downs Surgical , Ltd. as applicant

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Related Devices (Code: HRX)

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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