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FDA 510(k)

MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE

K-Number: K860102 · 1986-02-12

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

Device Summary

MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE 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 K860102. The device is classified under product code FHP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE?

MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is Endotherapeutics. The 510(k) number is K860102.

When did MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE receive FDA 510(k) clearance?

MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE received FDA 510(k) clearance on 1986-02-12, under 510(k) number K860102.

Who is the listed applicant for MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE?

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. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE?

The FDA product code for MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE is FHP.

Related Clinical Trials

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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 SLEEVEK860103MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVEK852031ENDOPORT 5MMK844619ENDONEEDLEK841716ENDOPORT EROCAR

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Related Devices (Code: FHP)

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.

K910855ENDOPATH VERESS NEEDLESymbiosis Corp.

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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