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FDA 510(k)

KLEIN LAMPREY-CANNULA(TM)

K-Number: K901718 · 1990-05-24

ApplicantJeff Klein Surgical, Inc.
Decision Date1990-05-24
Product CodeGEA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KLEIN LAMPREY-CANNULA(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 1990-05-24 under 510(k) number K901718. The device is classified under product code GEA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLEIN LAMPREY-CANNULA(TM)?

KLEIN LAMPREY-CANNULA(TM) is a medical device that received FDA 510(k) clearance on 1990-05-24. The listed applicant is Jeff Klein Surgical, Inc.. The 510(k) number is K901718.

When did KLEIN LAMPREY-CANNULA(TM) receive FDA 510(k) clearance?

KLEIN LAMPREY-CANNULA(TM) received FDA 510(k) clearance on 1990-05-24, under 510(k) number K901718.

Who is the listed applicant for KLEIN LAMPREY-CANNULA(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 LAMPREY-CANNULA(TM)?

The FDA product code for KLEIN LAMPREY-CANNULA(TM) is GEA.

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.

K901717KLEIN MICRO-CANNULA(TM)K901719KLEIN MICRO-CANNULA HANDLE(TM)K901716KLEIN CONNECTOR(TM)K901715KLEIN CORK(TM)

Related Devices (Code: GEA)

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.

K003965MRI SAFE INSTRUMENTSAesculap, Inc.K982472GENICON TROCARGenicon, LCK954599CONMED TROGARD ELECTRONIC TROCAR SYSTEMConmedcorpK922460ORIGIN SECONDARY CANNULA AND TROCAROrigin Medsystems, Inc.K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEETHICON, Inc.K911262DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCERETHICON, 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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