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FDA 510(k)

EOS BRAND DISPOSABLE PROCTOSCOPE

K-Number: K954614 · 1996-04-10

ApplicantNorth Eos Industries, Inc.
Decision Date1996-04-10
Product CodeGCP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EOS BRAND DISPOSABLE PROCTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is North Eos Industries, Inc.. It received FDA 510(k) clearance on 1996-04-10 under 510(k) number K954614. The device is classified under product code GCP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EOS BRAND DISPOSABLE PROCTOSCOPE?

EOS BRAND DISPOSABLE PROCTOSCOPE is a medical device that received FDA 510(k) clearance on 1996-04-10. The listed applicant is North Eos Industries, Inc.. The 510(k) number is K954614.

When did EOS BRAND DISPOSABLE PROCTOSCOPE receive FDA 510(k) clearance?

EOS BRAND DISPOSABLE PROCTOSCOPE received FDA 510(k) clearance on 1996-04-10, under 510(k) number K954614.

Who is the listed applicant for EOS BRAND DISPOSABLE PROCTOSCOPE?

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

What is the FDA product code for EOS BRAND DISPOSABLE PROCTOSCOPE?

The FDA product code for EOS BRAND DISPOSABLE PROCTOSCOPE is GCP.

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.

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Other records listing North Eos Industries, 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.

K963685EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLERK963377EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC

Related Devices (Code: GCP)

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.

K896505PORGES UNIVERSAL HANDLESPorges Corp.K896008MODEL 6500 MERCURY ARC LIGHT SOURCEMedical Dynamics, Inc.K862424STEERABLE CATHETER SYSTEMEndovationsK860103MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVEEndotherapeuticsK843683MODULAR FIBERSCOPE SYSTEMReichert Scientific InstrumentsK833859TAMPONADE BALLOON CUFFAmerican Endoscopy, Inc.

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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