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510(k) K992141

Device
OLYMPUS WORKING ELEMENT FOR PROBES
Applicant
OLYMPUS WINTER & IBE GMBH
510(k) number
K992141
Product code
FDC  
Decision
Substantially Equivalent (SESE)
Decision date
1999-09-29
Date received
1999-06-24
Regulation
876.1500
Classification name
Resectoscope, Working Element
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LAURA STORMS-TYLER
Address
Two Corporate Center Dr. Melville NY US 11747 11747

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FDC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021166ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BRAcmi-Circon Corporation2002-05-09
K991426MAHE INSTRUMENTSMahe Intl., Inc.1999-08-05
K942626CONTINUOUS FLOW BIOPSY PROBEGm Engineering, Inc.1995-05-30
K933962GM CONTINUOUS FLOW BIOPSY PROBEGm Engineering, Inc.1994-02-25
K895643MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEMOrthoconcept, Inc.1989-10-17
K894363UROPUMP* FLUID MANAGEMENT SYSTEMOrthoconcept, Inc.1989-08-11
K842997LASER RECTOSCOPE SET 784Laser Industries , Ltd.1984-08-27
K760182SHEATH, RESECTOSCOPEV. Mueller O.V. Baxter Healthcare Corp.1976-12-02
K760184ELEMENT, WORKINGV. Mueller O.V. Baxter Healthcare Corp.1976-12-02
K760174ADAPTER, RESECTOSCOPEV. Mueller O.V. Baxter Healthcare Corp.1976-08-30

Legacy Summary#

summary

FDA Review#

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