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FDA 510(k)

ECA

K-Number: K811397 · 1981-07-02

ApplicantGillco, Inc.
Decision Date1981-07-02
Product CodeFOA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ECA is the device name listed in this FDA 510(k) record. The listed applicant is Gillco, Inc.. It received FDA 510(k) clearance on 1981-07-02 under 510(k) number K811397. The device is classified under product code FOA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECA?

ECA is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is Gillco, Inc.. The 510(k) number is K811397.

When did ECA receive FDA 510(k) clearance?

ECA received FDA 510(k) clearance on 1981-07-02, under 510(k) number K811397.

Who is the listed applicant for ECA?

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

What is the FDA product code for ECA?

The FDA product code for ECA is FOA.

Related PubMed Literature

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.

PMID: 42834824India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.Expert review of medical devices ()PMID: 42825233Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.Neurosurgery practice ()PMID: 42618680Failure modes in soft-tissue surgical robots: an adjudicated FDA recall cohort, 2005-2026.Journal of robotic surgery ()PMID: 42566203Premarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices.JAMA health forum ()

Related Devices (Code: FOA)

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

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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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