FDA.report

510(k) K221893

Device
KARL STORZ Bipolar Resectoscopes with HF Cable
Applicant
Karl Storz Endoscopy America, Inc.
510(k) number
K221893
Product code
FJL
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-17
Date received
2022-06-29
Regulation
876.1500
Classification name
Resectoscope
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Leigh Spotten
Address
2151 E. Grand Ave. El Segundo CA US 90245 90245

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
04048438005392n.a.Karl Storz GmbH & Co. KG2024-10-04

Other 510(k) Records For Product Code FJL

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K962506[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]Gynecare Innovation Center1996-09-16
K960757KARL STORZ URETER RESECTOSCOPEKARL STORZ Endoscopy-America, Inc.1996-05-01
K954050RESECTOSCOPESKARL STORZ Endoscopy-America, Inc.1995-11-22