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FDA 510(k)

ENDOPORT 5MM

K-Number: K852031 · 1985-08-13

ApplicantEndotherapeutics
Decision Date1985-08-13
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOPORT 5MM is the device name listed in this FDA 510(k) record. The listed applicant is Endotherapeutics. It received FDA 510(k) clearance on 1985-08-13 under 510(k) number K852031. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPORT 5MM?

ENDOPORT 5MM is a medical device that received FDA 510(k) clearance on 1985-08-13. The listed applicant is Endotherapeutics. The 510(k) number is K852031.

When did ENDOPORT 5MM receive FDA 510(k) clearance?

ENDOPORT 5MM received FDA 510(k) clearance on 1985-08-13, under 510(k) number K852031.

Who is the listed applicant for ENDOPORT 5MM?

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 ENDOPORT 5MM?

The FDA product code for ENDOPORT 5MM is HET.

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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 NEEDLEK860103MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVEK844619ENDONEEDLEK841716ENDOPORT EROCAR

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Related Devices (Code: HET)

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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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