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FDA 510(k)

MEDIFLEX INJECTION CAP

K-Number: K855039 · 1986-01-24

ApplicantMediflex Intl.
Decision Date1986-01-24
Product CodeGCE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDIFLEX INJECTION CAP is the device name listed in this FDA 510(k) record. The listed applicant is Mediflex Intl.. It received FDA 510(k) clearance on 1986-01-24 under 510(k) number K855039. The device is classified under product code GCE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIFLEX INJECTION CAP?

MEDIFLEX INJECTION CAP is a medical device that received FDA 510(k) clearance on 1986-01-24. The listed applicant is Mediflex Intl.. The 510(k) number is K855039.

When did MEDIFLEX INJECTION CAP receive FDA 510(k) clearance?

MEDIFLEX INJECTION CAP received FDA 510(k) clearance on 1986-01-24, under 510(k) number K855039.

Who is the listed applicant for MEDIFLEX INJECTION CAP?

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

What is the FDA product code for MEDIFLEX INJECTION CAP?

The FDA product code for MEDIFLEX INJECTION CAP is GCE.

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Other records listing Mediflex Intl. 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.

K915140PRIMARY DRESSING TRAYK900841HEMODIALYSIS TRANSDUCER PROTECTORK891077MEDIVERSE PARENTERAL NUTRITION BAGK884243BLOOD TUBING SETK863496MEDIFLEX TRANSDUCER PROTECTORK854346MEDIFLEX DISPOSABLE TUBING CLAMP

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Related Devices (Code: GCE)

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.

K901716KLEIN CONNECTOR(TM)Jeff Klein Surgical, Inc.K901715KLEIN CORK(TM)Jeff Klein Surgical, Inc.K801680BETA-CAP II ADAPTERQuinton, 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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