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FDA 510(k)

GARDNER KUPHOSIS DISTRACTOR

K-Number: K802851 · 1981-02-17

ApplicantDowns Surgical , Ltd.
Decision Date1981-02-17
Product Code
DecisionSubstantially Equivalent

Device Summary

GARDNER KUPHOSIS DISTRACTOR 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 1981-02-17 under 510(k) number K802851. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GARDNER KUPHOSIS DISTRACTOR?

GARDNER KUPHOSIS DISTRACTOR is a medical device that received FDA 510(k) clearance on 1981-02-17. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K802851.

When did GARDNER KUPHOSIS DISTRACTOR receive FDA 510(k) clearance?

GARDNER KUPHOSIS DISTRACTOR received FDA 510(k) clearance on 1981-02-17, under 510(k) number K802851.

Who is the listed applicant for GARDNER KUPHOSIS DISTRACTOR?

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

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Other records listing Downs Surgical , Ltd. as applicant

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.

K903750ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-EK903747ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-UK903749ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-UK903748ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-VK900609SHEPPERD STRAIGHT AND CURVED NEEDLESK900616SHEPPERD CUTTING FORCEPS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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