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FDA 510(k)

KLEIN CORK(TM)

K-Number: K901715 · 1990-05-11

ApplicantJeff Klein Surgical, Inc.
Decision Date1990-05-11
Product CodeGCE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KLEIN CORK(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Jeff Klein Surgical, Inc.. It received FDA 510(k) clearance on 1990-05-11 under 510(k) number K901715. 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 KLEIN CORK(TM)?

KLEIN CORK(TM) is a medical device that received FDA 510(k) clearance on 1990-05-11. The listed applicant is Jeff Klein Surgical, Inc.. The 510(k) number is K901715.

When did KLEIN CORK(TM) receive FDA 510(k) clearance?

KLEIN CORK(TM) received FDA 510(k) clearance on 1990-05-11, under 510(k) number K901715.

Who is the listed applicant for KLEIN CORK(TM)?

The FDA 510(k) record lists Jeff Klein Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLEIN CORK(TM)?

The FDA product code for KLEIN CORK(TM) is GCE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Jeff Klein Surgical, 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.

K901718KLEIN LAMPREY-CANNULA(TM)K901717KLEIN MICRO-CANNULA(TM)K901719KLEIN MICRO-CANNULA HANDLE(TM)K901716KLEIN CONNECTOR(TM)

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.K855039MEDIFLEX INJECTION CAPMediflex Intl.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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