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FDA 510(k)

MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE

K-Number: K860103 · 1986-02-12

ApplicantEndotherapeutics
Decision Date1986-02-12
Product CodeGCP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Endotherapeutics. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K860103. 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 MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE?

MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is Endotherapeutics. The 510(k) number is K860103.

When did MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE receive FDA 510(k) clearance?

MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE received FDA 510(k) clearance on 1986-02-12, under 510(k) number K860103.

Who is the listed applicant for MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE?

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

What is the FDA product code for MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE?

The FDA product code for MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE is GCP.

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Other records listing Endotherapeutics 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.

K870855UROSCANK860192ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVEK860102MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLEK852031ENDOPORT 5MMK844619ENDONEEDLEK841716ENDOPORT EROCAR

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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.

K954614EOS BRAND DISPOSABLE PROCTOSCOPENorth Eos Industries, Inc.K896505PORGES UNIVERSAL HANDLESPorges Corp.K896008MODEL 6500 MERCURY ARC LIGHT SOURCEMedical Dynamics, Inc.K862424STEERABLE CATHETER SYSTEMEndovationsK843683MODULAR 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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