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FDA 510(k)

GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO

K-Number: K851242 · 1985-09-11

ApplicantCook, Inc.
Decision Date1985-09-11
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1985-09-11 under 510(k) number K851242. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO?

GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO is a medical device that received FDA 510(k) clearance on 1985-09-11. The listed applicant is Cook, Inc.. The 510(k) number is K851242.

When did GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO receive FDA 510(k) clearance?

GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO received FDA 510(k) clearance on 1985-09-11, under 510(k) number K851242.

Who is the listed applicant for GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO?

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

What is the FDA product code for GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO?

The FDA product code for GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO is FGE.

Related Clinical Trials

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.

Other records listing Cook, Inc. 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.

View all 184 devices →

Related Devices (Code: FGE)

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.

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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