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FDA 510(k)

STOMACH, GASTRO-ENTEROSTOMY

K-Number: K902421 · 1990-11-20

ApplicantGainor Medical Europe, Ltd.
Decision Date1990-11-20
Product CodeKDH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STOMACH, GASTRO-ENTEROSTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical Europe, Ltd.. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K902421. The device is classified under product code KDH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOMACH, GASTRO-ENTEROSTOMY?

STOMACH, GASTRO-ENTEROSTOMY is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Gainor Medical Europe, Ltd.. The 510(k) number is K902421.

When did STOMACH, GASTRO-ENTEROSTOMY receive FDA 510(k) clearance?

STOMACH, GASTRO-ENTEROSTOMY received FDA 510(k) clearance on 1990-11-20, under 510(k) number K902421.

Who is the listed applicant for STOMACH, GASTRO-ENTEROSTOMY?

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

What is the FDA product code for STOMACH, GASTRO-ENTEROSTOMY?

The FDA product code for STOMACH, GASTRO-ENTEROSTOMY is KDH.

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Other records listing Gainor Medical Europe, 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.

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Related Devices (Code: KDH)

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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